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

Catalog Number 500-BAS-UK-10

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to heartsine technologies ltd for investigation.Upon completion of this investigation a follow up report will be submitted detailing the conclusions of this investigation.The serial number is corrected from (b)(4).

Event Description

No voice prompts may contribute to adverse event.No patient involvement.

Manufacturer Narrative

Heartsine's investigation of the device confirmed the reported fault, as on receipt the device was issuing no audio prompts.The fault was attributed to a failure of the speaker, which may have been caused by external mechanical influences (e.G.Vibrations or impact).The failure of the speaker did not prevent the device from delivering shock therapy, as demonstrated during the investigation, as the device continued to prompt therapy via the instructional leds.However, absence of voice prompts may lead to an inability understanding how to use the device correctly, which could result in adverse consequences.

Event Description

No voice prompts may contribute to adverse event.No patient involvement.

• Brand Name: PACKAGE,500P,PP03,INTL EN,500-BAS-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: 12056718
• MDR Text Key: 260964102
• Report Number: 3004123209-2021-00170
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 500-BAS-UK-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1