MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 450P,PP03J,JA,450-STR-JA-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	SAM 450P
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
No green status indicator.No patient involvement.
Additional Manufacturer Narrative
Misaligned membrane tail.Upon receipt, the green status indicator was extinguished, as per the reported fault.This was attributed to a misaligned membrane tail within the j11 connector.This had resulted in no connection between track 4 (status_led_green) and its associated pin on the j11 connector.As no fault was identified on the j11 connector, and the fault could not be replicated after correctly reinstalling the membrane within the connector, the reported failure had been due to the misalignment of the membrane tail.
Event or Problem Description
No green status indicator.No patient involvement.

• Brand Name: PACKAGE, 450P,PP03J,JA,450-STR-JA-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: 11391463
• Report Number: 3004123209-2021-00060
• Device Sequence Number: 4048587
• Product Code: MKJ
• UDI-Device Identifier: M727SAM450P
• UDI-Public: M727SAM450P
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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 450P
• Device Catalogue Number: 450-STR-JA-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1