MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 360P, PP03, UK, 360-STR-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number 360-STR-UK-10

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

Heartsine has requested return of the complaint device.Upon its receipt, the device will be investigated and a follow up report submitted within 30 days documenting the findings.

Event Description

Absence of voice prompts may lead to adverse consequences if device use is required.No patient involved in this event.

Event Description

Absence of voice prompts may lead to adverse consequences if device use is required.No patient involved in this event.

Manufacturer Narrative

Heartsine's investigation of the device confirmed the reported fault as the device would not issue audio prompts.Upon visual inspection, the reported fault was attributed to a broken speaker cable which was identified as being broken in the region where the rim of the upper case meets the lower case.This indicates that the cable had been damaged during pairing of the two cases at manufacture.Whilst the device performed a test shock during testing, absence of voice prompts may lead to an inability understanding how to use the device correctly which could result in adverse consequences.

• Brand Name: PACKAGE, 360P, PP03, UK, 360-STR-UK-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 207 airport road west; belfast BT3 9 ED; EI BT3 9ED
• MDR Report Key: 12106032
• MDR Text Key: 262166126
• Report Number: 3004123209-2021-00175
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 360-STR-UK-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 08/31/2021
• Supplement Dates FDA Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1