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

Model Number	SAM 350P
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Heartsine has received the device for investigation and a follow up report will be submitted including the conclusions of the investigation.
Event or Problem Description
Reported that the device is not delivering a shock during testing.No patient involvement.
Additional Manufacturer Narrative
Heartsine's investigation of the device confirmed the reported fault as during the investigation the device delivered zero shock energy, powering of with a "warning, device service required¿ prompt.The fault was attributed to a high voltage breakdown of the output circuitry.Due to the damage caused by the high voltage breakdown, the investigation was unable to accurately determine the source of the issue.Failure of the device to deliver shock therapy may prevent defibrillation, which could result in an adverse consequences.
Event or Problem Description
Reported that the device is not delivering a shock during testing.No patient involvement.

• Brand Name: PACKAGE, 350P, 1X PAD-PAK-03, GERMAN, 350-STR-DE-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: 12194765
• Report Number: 3004123209-2021-00185
• Device Sequence Number: 11778876
• Product Code: MKJ
• UDI-Device Identifier: M727SAM350P
• UDI-Public: M727SAM350P
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P160008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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-DE-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1