MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P, 1X PAD-PAK-03, GERMAN, 350-STR-DE-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number 350P

Device Problem Failure to Deliver Shock/Stimulation (1133)

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

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

Due to character limitations section e1, initial reporter phone, was left blank.The initial reporter¿s phone number is (b)(6).Heartsine has received the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.

Event Description

The distributor contacted heartsine to report that their customer's device does not provide a shock.This issue has the potential to either delay, or prevent, defibrillation from being delivered.There was no report of patient use associated with the reported event.

Manufacturer Narrative

Heartsine's investigation of the device confirmed the reported fault as upon return, the device did not deliver shock energy.The reported fault was attributed to a failure of capacitor c22, which forms part of phase 1 discharge control circuitry used to deliver phase 1 shock energy.The device was scrapped by heartsine and the customer was provided with a replacement device.

Event Description

The distributor contacted heartsine to report that their customer's device does not provide a shock.This issue has the potential to either delay, or prevent, defibrillation from being delivered.There was no report of patient use associated with the reported event.

• Brand Name: PACKAGE, 350P, 1X PAD-PAK-03, GERMAN, 350-STR-DE-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 207 airport road west; belfast BT3 9 ED; EI BT3 9ED
• Manufacturer (Section G): HEARTSINE TECHNOLOGIES LTD; 207 airport road west; belfast BT3 9 ED; EI BT3 9ED
• Manufacturer Contact: dara friedman ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 17863219
• MDR Text Key: 324832924
• Report Number: 3004123209-2023-00137
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 350P
• Device Catalogue Number: 350-STR-DE-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1