MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 500P, 1 PAD-PAK-01, USB, ENGLISH, 500-BAS-CN-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number 500-BAS-CN-10

Device Problems Failure to Power Up (1476); Electrical Power Problem (2925); Failure to Shut Off (2939)

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

Event Date 04/12/2021

Event Type  malfunction  

Event Description

Device will not switch on.No patient involvement.

Event Description

Device will not switch on.No patient involvement.

Manufacturer Narrative

The device was not returned to heartsine for investigation.No additional information will be forthcoming at this time; if the device is returned to the manufacturer the investigation will be reopened.H3 other text: device not evaluated by manufacturer.

Manufacturer Narrative

Heartsine's investigation of the device confirmed the reported fault, as upon receipt the device could not be powered on.This fault was attributed to membrane failure due to suspected storage outside of the indicated conditions.The corrosion observed on the membrane pcb would indicate the device had been stored outside of the indicated conditions.However, this could not be verified by other means, as there was no corrosion observed on the exterior of the device.Whilst the device could provide a test shock during the investigation, failure to power on a device may prevent or delay defibrillation therapy, which could result in adverse consequences.

Event Description

The customer contacted heartsine to report that their device will not switch on.Inability to switch on a device may prevent or delay defibrillation therapy.The was no patient involvement reported with the event.

• Brand Name: PACKAGE, 500P, 1 PAD-PAK-01, USB, ENGLISH, 500-BAS-CN-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: 11768702
• MDR Text Key: 251285803
• Report Number: 3004123209-2021-00133
• 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: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 500-BAS-CN-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1