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

Catalog Number UNK_BEL

Device Problems Unintended Power Up (1162); Defective Device (2588)

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

Event Date 04/28/2021

Event Type  malfunction  

Event Description

Device switching on automatically, memory full.No patient involvement.

Event Description

Device switching on automatically, memory full.No patient involvement.

Manufacturer Narrative

The device was not returned to heartsine for investigation.No additional information will be forthcoming at this time; if the device is returned to the manufacturer the investigation will be reopened.H3 other text: device not evaluated by manufacturer.

• 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: 11782008
• MDR Text Key: 251669635
• Report Number: 3004123209-2021-00138
• 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: 06/29/2021

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?: No
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0124-2013
• Patient Sequence Number: 1