MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD UNKNOWN_MEDICAL - BELFAST_PRODUCT; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number UNK_BEL

Device Problem No Audible Prompt/Feedback (2282)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

Correction to serial number from (b)(4).Heartsine has received the device for investigation.Conclusion of the investigation will be reported in a follow up report.

Event Description

Absence of voice prompts may lead to an adverse event.No patient involvement.

Event Description

Absence of voice prompts may lead to an adverse event.No patient involvement.

Manufacturer Narrative

Heartsine's investigation of the device confirmed the reported fault, as the device was issuing no audio prompts.The fault was attributed to a continuity issue across the black speak cable which was observed as the device was giving voice prompts intermittently when the black speaker cable was being manipulated.The failure of the speaker may have been due to external mechanical influences (e.G.Vibrations or impact).The failure of the speaker did not prevent the device from delivering shock therapy, however absence of voice prompts may lead to an inability understanding how to use the device correctly which could result in adverse consequences.

• Brand Name: UNKNOWN_MEDICAL - BELFAST_PRODUCT
• 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: 12133443
• MDR Text Key: 262744092
• Report Number: 3004123209-2021-00178
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K014067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_BEL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1