MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 500P, PP03, UK, 500-STR-UK-10; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 500P

Device Problem Failure to Analyze Signal (1539)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2024

Event Type  malfunction  

Manufacturer Narrative

Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.The sam 500p device is not available for distribution in the united states but is similar to the sam 350p and 450p which is distributed in the united states.

Event Description

The customer contacted heartsine to report that their device was unable to assess a heart rhythm.In this state the device would be inoperable and defibrillation therapy would not be available if needed.The patient involved in the reported event is deceased.

Event Description

The customer contacted heartsine to report that their device was unable to assess a heart rhythm.In this state the device would be inoperable and defibrillation therapy would not be available if needed.The patient involved in the reported event is deceased.

Manufacturer Narrative

Heartsine's investigation of the device was unable to duplicate the reported fault.The device performed to specification throughout the investigation.Information from the device memory indicates the device successfully detected an in-range impedance and delivered one shock on the (b)(6) 2023, which would indicate no fault with the impedance sensing at this time.It is likely that the reported issue related to situational factors, e.G., incorrect placement of pads on patient, or the pad-pak being incorrectly seated within the device.Therefore, the reported fault was attributed to a potential use error.The device was scrapped by heartsine.The sam 500p device is not available for distribution in the united states but is similar to the sam 350p and 450p which is distributed in the united states.

• Brand Name: PACKAGE, 500P, PP03, UK, 500-STR-UK-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• 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: brian blakeslee ; 207 airport road west; belfast BT3 9-ED ; EI BT3 9ED ; 4258674577
• MDR Report Key: 18984082
• MDR Text Key: 338657637
• Report Number: 3004123209-2024-00035
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 500P
• Device Catalogue Number: 500-STR-UK-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death