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

Catalog Number 500-BAS-UK-10

Device Problems Impedance Problem (2950); Audible Prompt/Feedback Problem (4020)

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

Event Date 06/18/2021

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.

Manufacturer Narrative

Heartsine's investigation confirmed the reported fault as the device was found to be giving incorrect child patient prompts with an adult pad-pak installed.The investigation determined a failure of the reed switch which controls whether the device recognises an adult or child patient pad-pak insertion.If an child patient is detected but an adult is connected, the higher the impedance the lower the shock energy.There is potential to cause an adverse event but it is dependent on the impedance of the patient.

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.

• 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: 12171567
• MDR Text Key: 263539781
• Report Number: 3004123209-2021-00183
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 500-BAS-UK-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1