FDA Adverse Event Malfunction Summary report: N

UNKNOWN_MEDICAL - BELFAST_PRODUCT

MDR report key: 16635159 · Received March 29, 2023

Report

Report Number: 3004123209-2023-00031
Event Type: Malfunction
Date Received: March 29, 2023
Date of Event: March 7, 2023
Report Date: May 15, 2023
Manufacturer: HEARTSINE TECHNOLOGIES LTD - MHRA ORG ID:30675
Product Code: MKJ
PMA / PMN Number: P160008
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

HEARTSINE HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER REGARDING THE STATUS OF THEIR DEVICE, BUT NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER. THE DEVICE WAS NOT RETURNED TO HEARTSINE FOR INVESTIGATION. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING AT THIS TIME. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF THE DEVICE IS RETURNED TO THE MANUFACTURER THE INVESTIGATION WILL BE REOPENED. H3 OTHER TEXT : DEVICE NOT RETURNED FOR EVALUATION.

Additional Manufacturer Narrative · 0

HEARTSINE HAS REQUESTED RETURN OF THE DEVICE FOR INVESTIGATION. UPON COMPLETION, THE CONCLUSIONS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

Description of Event or Problem · 0

THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DOES NOT POWER ON. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

Description of Event or Problem · 0

THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DOES NOT POWER ON. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
954092	UNKNOWN_MEDICAL - BELFAST_PRODUCT	AUTOMATED EXTERNAL DEFIBRILLATOR	MKJ	HEARTSINE TECHNOLOGIES LTD - MHRA ORG ID:30675	300P

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown