MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 500P, 1 PAD-PAK-01, USB, ENGLISH, 500-STR-CN-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number 500-STR-CN-10

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 07/29/2020

Event Type  malfunction  

Event Description

When you press the ¿on/off¿ button, there are no audible prompts and the aed is flashing red.Also when you try to turn off the aed, it says device service required.There is no patient involved in this event.

• Brand Name: PACKAGE, 500P, 1 PAD-PAK-01, USB, ENGLISH, 500-STR-CN-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: 10384572
• MDR Text Key: 203288001
• Report Number: 3004123209-2020-00249
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 500-STR-CN-10
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/29/2020
• 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