MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number 80515-000040

Device Problem No Device Output (1435)

Patient Problem No Patient Involvement (2645)

Event Date 03/25/2020

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2015058.(b)(4).

Event Description

There was no patient involved in this event.All led light no respond during saver evo test.

• Brand Name: PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED; IE BT3 9ED
• Manufacturer (Section G): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED; IE BT3 9ED
• Manufacturer Contact: rebecca funston ; 203 airport road west; belfast BT3 9-ED ; IE BT3 9ED ; 2890939400
• MDR Report Key: 9961367
• MDR Text Key: 188019311
• Report Number: 3004123209-2020-00093
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: SG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 80515-000040
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1