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	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device will be investigated by heeartsine.Within 30 days of its conclusion, heartsine will submit a follow up report detailing the findings of the investigation.
Event or Problem Description
Inability to switch on the device could lead to adverse consequences for a patient.No patient involved in this event.
Additional Manufacturer Narrative
Heartsine's investigation of the device confirmed the reported fault, as on receipt the device could not be powered off via the on/off button.Investigation of the device confirmed the fault was attributed to corrosion on the membrane tail.Corrosion was observed on track 13 (on_button), which led to a high resistance on this line, causing the device to be unable to power off.Corrosion on the membrane tail was suspected to be due to storage outside of indicated conditions.Inability of the device to turn off will not affect its ability to perform shock therapy, and a test shock was successfully performed during testing of the device.
Event or Problem Description
Inability to switch on the device could lead to adverse consequences for a patient.No patient involved in 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: 12106030
• Report Number: 3004123209-2021-00176
• Device Sequence Number: 11712992
• 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): 08/20/2021

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: 06/28/2021
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1