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	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The status indicator flashed red and it was found that the device could not turn on when the on/off button was pressed.There was no patient involved in this event.
Additional Manufacturer Narrative
The failure of the device to power on was attributed to a depleted cell in the returned pad-pak however the root cause for its depletion could not be determined.The device performed to specification with a test pad-pak.The device would not have been able to deliver therapy, unless the pad-pak was replaced, had it been used in a sca situation.
Event or Problem Description
The status indicator flashed red and it was found that the device could not turn on when the on/off button was pressed.There was no patient involved in this event.

• 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: 10883103
• Report Number: 3004123209-2020-00369
• Device Sequence Number: 3045486
• 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): 06/25/2021

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: 80515-000128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1