MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,450P,PP01,EN,450-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	SAM450P
Medical Device Problem Codes	Failure to Power Up (1476); Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
Event or Problem Description
Report alleges on/off button is faulty.Failure to power on device may prevent or delay defibrillation, which could cause an adverse event.No patient involvement.
Event or Problem Description
Report alleges on/off button is faulty.Failure to power on device may prevent or delay defibrillation, which could cause an adverse event.No patient involvement.
Additional Manufacturer Narrative
The device was not returned to heartsine for investigation.No additional information will be forthcoming at this time; if the device is returned to the manufacturer the investigation will be reopened.H3 other text : device not returned for evaluation.
Event or Problem Description
The customer contacted heartsine to report that their device's on/off button is faulty.Failure to power on device may prevent or delay defibrillation, which could cause an adverse event.There was no patient involvement reported with this event.
Additional Manufacturer Narrative
Heartsine's investigation confirmed the reported fault as upon receipt the device could be powered on but could not be powered off via the on/off button.The fault was attributed to a misaligned membrane tail, as evidenced by clamp marks between its tracks and damage to the extreme right of the tail.The device was scrapped by heartsine and the customer was provided with a replacement device.

• Brand Name: PACKAGE,450P,PP01,EN,450-STR-US-10
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 207 airport road west; belfast BT3 9 ED; EI BT3 9ED
• Manufacturer (Section G): HEARTSINE TECHNOLOGIES LTD; 207 airport road west; belfast BT3 9 ED; EI BT3 9ED
• Manufacturer Contact: todd bandy ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 12346895
• Report Number: 3004123209-2021-00216
• Device Sequence Number: 4648730
• Product Code: MKJ
• UDI-Device Identifier: 05060167120695
• UDI-Public: 05060167120695
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 11/17/2021

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: Lay User/Patient
• Device Model Number: SAM450P
• Device Catalogue Number: 450-STR-US-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 10/01/2021; 11/17/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 10/05/2021; 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown