MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number SAM 350P

Device Problem Failure to Shut Off (2939)

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

Event Date 04/23/2021

Event Type  malfunction  

Event Description

Device won't switch off.No patient involvement.

Manufacturer Narrative

Heartsine's investigation of the device concluded that the reported fault was attributed to corrosion on the membrane tail due to suspected storage outside of indicated conditions.Corrosion on the membrane tail did not impact the device's ability to provide shock therapy.

Event Description

Device won't switch off.No patient involvement.

• Brand Name: PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10
• 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: 11782075
• MDR Text Key: 251671547
• Report Number: 3004123209-2021-00141
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: M727SAM350P
• UDI-Public: M727SAM350P
• Combination Product (y/n): N
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

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 Model Number: SAM 350P
• Device Catalogue Number: 350-BAS-UK-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1