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	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device service required prompt.No patient involvement.
Event or Problem Description
Device service required prompt.No patient involvement.
Additional Manufacturer Narrative
Bt1 coin cell detached from pcba due to impact damage.Upon receipt at heartsine, damage was observed on the lower and upper-case assembly, which would indicate the device had sustained an impact.Visual inspection of the device revealed the bt1 coin cell had become detached from the pcba.As the bt1 coin cell provides power for the rtc circuit, this had resulted rtc errors in the history log.The user would have been alerted with ¿warning, device service required¿ prompts, as per reported fault.

• 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; 203 airport road west; belfast BT3 9 ED; EI BT3 9ED
• MDR Report Key: 11671595
• Report Number: 3004123209-2021-00122
• Device Sequence Number: 4167579
• Product Code: MKJ
• UDI-Device Identifier: M727SAM350P
• UDI-Public: M727SAM350P
• Combination Product (Y/N): N
• Initial Reporter Country: GH
• 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): 04/30/2021

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 350P
• Device Catalogue Number: 350-STR-DE-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1