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

Model Number	SAM 350P
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Difficulty inserting pad pak.When inserted the red status led was illuminated and the device would not power on.No patient involvement.
Event or Problem Description
Difficulty inserting pad pak.When inserted the red status led was illuminated and the device would not power on.No patient involvement.
Additional 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
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 207 airport road west; belfast BT3 9 ED; EI BT3 9ED
• MDR Report Key: 11782077
• Report Number: 3004123209-2021-00150
• Device Sequence Number: 19826633
• Product Code: MKJ
• UDI-Device Identifier: M727SAM350P
• UDI-Public: M727SAM350P
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1