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

Model Number SAM350P

Device Problems Device Difficult to Setup or Prepare (1487); Output Problem (3005)

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

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.

Event Description

Complaint alleges that device is not operating as intended.This may leave to a delay or prevent defibrillation therapy, which may result in adverse consequences.No patient involvement.

Manufacturer Narrative

Heartsine's investigation of the device confirmed the reported fault as upon receipt the device could not be powered on with the returned pad-pak.This was attributed to corrosion on the membrane tail.The corrosion on the membrane tail would suggest that the device had been stored outside of the indicated conditions, although this could not be verified by other means.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 pad-pak is not detected.The complaint alleges that device is not operating as intended.This may delay or prevent defibrillation therapy, which may result in adverse consequences.There was no patient involvement reported with this event.

• Brand Name: PACKAGE 350P, 1X PAD-PAK-03, FRENCH, 350-STR-FR-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: todd bandy ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 12459131
• MDR Text Key: 272137072
• Report Number: 3004123209-2021-00232
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SAM350P
• Device Catalogue Number: 350-STR-FR-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2017
• 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