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

Model Number	SAM350P
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
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 requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
Event or Problem Description
Inability to use the device shock button, may prevent or delay defibrillation which could result in adverse consequences.No patient involvement.
Additional Manufacturer Narrative
Heartsine evaluated the customer's device and verified the event was logged in the device's memory; however, the reported issue could not be duplicated in testing, and the investigation was inconclusive as no fault was found on the returned device.The device was scrapped by heartsine and the customer was provided with a replacement device.
Event or Problem Description
The distributor contacted heartsine to report that their device was showing the "shock key stuck" error message.Inability to use the device shock button, may prevent or delay defibrillation which could result in adverse consequences.There was no patient involvement reported with this event.

• Brand Name: PACKAGE,350P,PP03,INTL EN,350-BAS-UK-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: 12317824
• Report Number: 3004123209-2021-00210
• Device Sequence Number: 3736546
• Product Code: MKJ
• UDI-Device Identifier: M727SAM350P
• UDI-Public: M727SAM350P
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 10/28/2021

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: Lay User/Patient
• Device Model Number: SAM350P
• Device Catalogue Number: 350-BAS-UK-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1