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 Failure to Power Up (1476); Defective Device (2588); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Heartsine has requested return of the device for investigation.Upon completion of the investigation a supplemental report will be submitted to summarise the findings.

Event Description

Device unresponsive with two different pad-paks.Inability to switch a device on will prevent the device's use during an event.No patient involvement.

Event Description

Device unresponsive with two different pad-paks.Inability to switch a device on will prevent the device's use during an event.No patient involvement.

Manufacturer Narrative

Heartsine's investigation of the device confirmed the reported fault as no status indicator was observed flashing and the device could not be powered on.This was attributed to significant corrosion within the device on multiple components and circuitries including the membrane tail, j11 connector, led drive circuits and rtc circuitry, root caused to adverse storage.Inability to power on the device may delay or prevent shock therapy, potentially resulting in adverse consequences.

• Brand Name: PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED; EI BT3 9ED
• MDR Report Key: 11900268
• MDR Text Key: 256165697
• Report Number: 3004123209-2021-00166
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• 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: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1