Alarm

Main information

  • Trade name:
  • Alarm, emergency assistance
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Alarm, emergency assistance
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218052
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218052

NPA Pty Ltd T/a Cura1 - Alarm, emergency assistance

ARTG entry for

Medical Device Included Class 1

Sponsor

NPA Pty Ltd T/a Cura1

Postal Address

10 Gray Street,KILKENNY, SA, 5009

Australia

ARTG Start Date

4/12/2013

Product category

Medical Device Class 1

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

NPA Pty Ltd T/a Cura1

10 Gray Street

KILKENNY, SA, 5009

Australia

Products

1. Alarm, emergency assistance

Product Type

Medical device system

Effective date

4/12/2013

GMDN

30087 Alarm, emergency assistance

Intended purpose

To alert staff and caregivers when a person in their care requires assistance or attention.

The System comprises of:

2501 Long Range Care Station

2502 Zone Protector

2503 Wireless Call Point

2504 Over Door Light

2505 Wireless PIR Sensor

2506 Nurse Call Pendant

2507 Wireless Waterproof Call Point

2508 Zone Protector Battery Pack

2509 Database Software

2543 Paging Interface

2547 POCSAG Paging Transmitter

2548 POCSAG Alphanumeric Pager

4103 Single Fold Floor Mat

4104 Dual Fold Floor Mat

4113 Single Fold Crash Mat

4114 Single Fold Crash Mat with Sensor Pad

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 02.12.2017 at 04:49:39 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

31-5-2018

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

Abbott is communicating to physicians about a field corrective action related to the HeartMate 3™ Left Ventricular Assist Device (LVAD). Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting.

FDA - U.S. Food and Drug Administration

22-5-2018

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.

FDA - U.S. Food and Drug Administration

18-3-2018

Medical Devices Safety Update Volume 6, Number 2, March 2018

Medical Devices Safety Update Volume 6, Number 2, March 2018

Preventable alarm issues; Review into cochlear implants; NHS cylinder alert; recent safety alerts

Therapeutic Goods Administration - Australia

There are no news related to this product.