MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number SAM500P

Device Problems Computer Software Problem (1112); Failure to Sense (1559); Device Sensing Problem (2917); Audible Prompt/Feedback Problem (4020)

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

Event Date 07/23/2021

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.

Event Description

As patient impedance increases, the sensing of a child patient when an adult pad-pak is inserted will likely result in a reduced shock energy being delivered to the patient which may result in adverse consequences.No patient involvement.

Event Description

The distributor contacted heartsine to report that their device prompted child patient with an adult pad-pak inserted.As patient impedance increases, the sensing of a child patient when an adult pad-pak is inserted will likely result in a reduced shock energy being delivered to the patient which may result in adverse consequences.There was no patient involvement reported with this event.

Manufacturer Narrative

Following further communication with the customer, it was determined that the reported fault was not that the device could not connect to saver evo, but that the device was prompting a child patient with an adult pad-pak, as originally reported.B5 has been updated to reflect this change.Heartsine's investigation of the device could not confirm the reported fault.The investigation was unable to confirm the customer reported issue of child patient prompt issued with an adult pad-pak installed.However upon receipt the instructional leds were failing to illuminate.This fault was attributed to a fractured solder joint, which had failed after dispatch from heartsine.The device was scrapped by heartsine and the customer was provided with a replacement device.

Manufacturer Narrative

Following further communication with the customer, it was determined that the reported fault was not that the device was prompting a child patient with an adult pad-pak, but that the device could not connect to saver evo.B5 has been updated to reflect this change.This is a non reportable event as there is no information presented to suggest that the device has critically malfunctioned, therefore there will be no follow up report pending the results of this investigation.

Event Description

There is no information to suggest that the device has critically malfunctioned and would be likely to cause or contribute to adverse consequences, should it be used in a patient event.No patient involvement.

• Brand Name: PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 207 airport road west; belfast BT3 9 ED; EI BT3 9ED
• MDR Report Key: 12286568
• MDR Text Key: 267215175
• Report Number: 3004123209-2021-00194
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SAM500P
• Device Catalogue Number: 500-BAS-UK-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Date Manufacturer Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1