MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P, PP07, UK, 350-STR-UK-AV; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number 350P

Device Problem Failure to Sense (1559)

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

Event Date 08/12/2022

Event Type  malfunction  

Manufacturer Narrative

Heartsine has received the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.Heartsine contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.

Event Description

A distributor contacted heartsine to report that a customer¿s device failed to detect patient and failed to progress past apply pads during patient event.Failure to progress past apply pads may delay or prevent defibrillation therapy.This issue is patient related; however there was no adverse event reported.

Event Description

A distributor contacted heartsine to report that a customer¿s device failed to detect patient and failed to progress past apply pads during patient event.Failure to progress past apply pads may delay or prevent defibrillation therapy.This issue is patient related; however there was no adverse event reported.

Manufacturer Narrative

Heartsine evaluated the customer's device but was unable to duplicate the reported issue.The device was found to be accurately measure impedance throughout the specified range, even under the stress of elevated temperature.No continuity issue was identified on the patient output cables and no fault found on the pogo pins that would have resulted in an impedance detection issue.The device delivered the shock therapy sequence without fault using the pad-pak suspected to have been used during the event.Furthermore, the device recorded ecg data accurately without noise or other abnormalities.Given no fault found on the sam 350p or returned pad-paks, the cause of the reported issue could not be conclusively determined.The device was scrapped by heartsine.

• Brand Name: PACKAGE, 350P, PP07, UK, 350-STR-UK-AV
• 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: todd bandy ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 15411221
• MDR Text Key: 302934520
• Report Number: 3004123209-2022-00134
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-UK-AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 10/03/2022
• Supplement Dates FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2021
• 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