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

Model Number	SAM 350P
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device switching on automatically.No patient involvement.
Event or Problem Description
Device switching on automatically.No patient involvement.
Additional Manufacturer Narrative
Heartsine contacted the customer on several occasions to request return of the device for investigation.The customer did not return the device in order for heartsine to determine the root cause of the reported fault.H3 other text: device not returned.

• Brand Name: PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED; EI BT3 9ED
• MDR Report Key: 11628476
• Report Number: 3004123209-2021-00109
• Device Sequence Number: 3098033
• Product Code: MKJ
• UDI-Device Identifier: M727SAM350P
• UDI-Public: M727SAM350P
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: P160008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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-BAS-UK-10
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1