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

Model Number SAM500P

Device Problems Failure to Sense (1559); Defibrillation/Stimulation Problem (1573); Inadequacy of Device Shape and/or Size (1583); Device Sensing Problem (2917); Audible Prompt/Feedback Problem (4020)

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

Event Date 08/16/2021

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 both the impedance of the patient and the switch failing.

Event Description

The distributor contacted heartsine to report that their device was prompting a child patient when an adult pad-pak was 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 the event.

• 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: 12346852
• MDR Text Key: 268768162
• Report Number: 3004123209-2021-00222
• 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
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• 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: 09/22/2021
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1