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 03/05/2021

Event Type  malfunction  

Event Description

Red status led and beep.No sound when power button is pressed.No patient involvement.

Event Description

Red status led and beep.No sound when power button is pressed.No patient involvement.

Manufacturer Narrative

Heartsine's investigation of the device determined that the device performed to specification throughout.However, damage to the pad-pak locator pins was noted which is suggestive of user error and an incorrectly seated pad-pak.The device was capable of delivering shock therapy during testing.

• Brand Name: UNKNOWN_MEDICAL - BELFAST_PRODUCT
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED; EI BT3 9ED
• MDR Report Key: 11782080
• MDR Text Key: 251665486
• Report Number: 3004123209-2021-00149
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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: 05/10/2021
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1