MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,USB,TH,350-BAS-TH-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number 350P

Device Problem Failure to Analyze Signal (1539)

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

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

Heartsine contacted the customer to request additional information on the patient.The customer provided heartsine with the available patient information.Patient fields in which information is not provided were intentionally left blank.Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.

Event Description

A distributor stryker to report that a customer¿s device did not analyze.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.

Manufacturer Narrative

Heartsine evaluated the customer's device but was unable to duplicate the reported issue.During the investigation, no fault was found on the sam 350p.The device was found to be accurately measure impedance throughout the specified range.The device delivered the test therapy sequence without fault using the returned pad-pak.However, on receipt the electrode pads of the returned pad-pak remained sealed within their foil pouch and the pads were still adhered to their plastic liner.This would indicate either the pad-pak not been used, or the pad-pak had been installed but the electrodes not deployed, therefore no patient impedance would have been detected.Heartsine informed the customer that the returned pad-pak electrodes were still sealed within their foil pouch and requested confirmation that the pads were applied (see communication log).No further response has been received.The returned pad-pak and aed combination would have been capable of analysing and delivering shock therapy, as demonstrated during the investigation.The device was scrapped by heartsine.

Event Description

A distributor stryker to report that a customer¿s device did not analyze.In this state the device may not be able to deliver defibrillation therapy if needed.There was no report of patient use associated to the reported event.

• Brand Name: PACKAGE,350P,PP03,USB,TH,350-BAS-TH-10
• Type of Device: 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: 15047957
• MDR Text Key: 304131503
• Report Number: 3004123209-2022-00103
• Device Sequence Number: 1
• Product Code: NSA
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 10/05/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 350P
• Device Catalogue Number: 350-BAS-TH-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 09/12/2022
• Supplement Dates FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2019
• 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 Age: 63 YR
• Patient Sex: Male