MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 450P, PP03J, JA 450-BAS-JA-08; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	SAM 450P
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
All lamps light up in self-test.There is no patient involved in this event.
Event or Problem Description
All lamps light up in self-test.There is no patient invovled in this event.
Additional Manufacturer Narrative
The device history records for the sam 450p device and pad-pak were reviewed and this confirmed that all manufacturing and quality checks and tests had been successfully completed.The sam 450p passed ¿out qat¿ from heartsine technologies on the 18th june 2020.The device was returned with a reported fault of all leds becoming illuminated.Information from the history log shows the device was installed on the 3rd august 2020 and power cycled multiple times prior to the date of complaint on the 4th august 2020, indicating that the user had become alerted to an issue at this time.Throughout the investigation, the status and icon leds did not illuminate outside of specification.No fault was identified on the membrane, microprocessor or elsewhere on the pcba that would have resulted in the erroneous illumination of the leds.The device was routinely power cycled over a total a total of 18 days while being subject to extensive thermal stress testing between 0-50°c and 95%rh, with no fault found on the led functionality during this time.As this was an isolated issue with no fault found on the device on receipt, no further investigation shall be carried out.Heartsine will continue to monitor for future reported faults of this nature.It is the policy of heartsine not to refurbish devices which have been returned from the field, after investigation, therefore this device shall be scrapped and replaced with a sam 450p.

• Brand Name: PACKAGE, 450P, PP03J, JA 450-BAS-JA-08
• 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: 10412350
• Report Number: 3004123209-2020-00262
• Device Sequence Number: 11348978
• Product Code: MKJ
• UDI-Device Identifier: M727SAM450P
• UDI-Public: M727SAM450P
• Combination Product (Y/N): N
• PMA/510(K) Number: P160008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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-BAS-JA-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1