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	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device switches on automatically.No patient involvement.
Additional Manufacturer Narrative
Corrosion on the membrane tail due to suspected storage outside of indicated conditions.During investigation, it was observed the device was powering on automatically with no status led illuminated.This was attributed to a corrosion bridge between track 13 (on_button) and 14 (key3_button), which had led to a short circuit between these lines.The fault had also led to an increased resistance through track 13, resulting in the inability to power off the device.An additional corrosion bridge was observed between tracks 5 (status_led_a) and 6 (right_pad_led).As track 5 provides the 18v supply for the status leds, this had prevented the status leds from flashing.
Event or Problem Description
Device switches on automatically.No patient involvement.

• 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: 11628487
• Report Number: 3004123209-2021-00114
• Device Sequence Number: 16918554
• Product Code: MKJ
• UDI-Device Identifier: M727SAM350P
• UDI-Public: M727SAM350P
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/18/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1