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 Product Quality Problem (1506); Device Sensing Problem (2917); Audible Prompt/Feedback Problem (4020)

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

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

The returned device will be investigated by heartsine and a follow up report submitted within 30 days of its closure detailing the conclusions of this investigation.

Event Description

The sensing of a child patient when an adult pad-pak is installed may result in an adverse event.There is no patient involvement in this case.

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

The sensing of a child patient when an adult pad-pak is installed may result in an adverse event.There is no patient involvement in this case.

• 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: 12105854
• MDR Text Key: 262078088
• Report Number: 3004123209-2021-00171
• 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: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• 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: 06/28/2021
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1