MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P,PP03J,JA,350-STR-JA-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number SAM 350P

Device Problems Device Alarm System (1012); Difficult to Insert (1316); Failure to Power Up (1476); Device Difficult to Setup or Prepare (1487)

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

Event Date 04/15/2021

Event Type  malfunction  

Event Description

Difficulty inserting pad pak.When inserted the red status led was illuminated and the device would not power on.No patient involvement.

Event Description

Difficulty inserting pad pak.When inserted the red status led was illuminated and the device would not power on.No patient involvement.

Manufacturer Narrative

Heartsine's investigation of the device could not confirm the reported fault.Throughout the investigation the device performed to specification.Information from the history log indicated a period when no log entries were recorded up to the (b)(6) 2021, with the reported fault being raised during this time on the (b)(6) 2021.This may suggest that the pad-pak had become incorrectly seated after initial installation, resulting in a poor connection, and the subsequent inability to power on the device alongside a red status led.However, given no fault found on the device and pad-pak plastics that would have inhibited the seating of the pad-pak, the investigation was unable to confirm this.

• Brand Name: PACKAGE, 350P,PP03J,JA,350-STR-JA-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 207 airport road west; belfast BT3 9 ED; EI BT3 9ED
• MDR Report Key: 11782077
• MDR Text Key: 251673171
• Report Number: 3004123209-2021-00150
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

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: No Information
• Device Model Number: SAM 350P
• Device Catalogue Number: 350-STR-JA-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/06/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1