MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number 80514-000139

Device Problems Device Remains Activated (1525); Defective Device (2588); Failure to Shut Off (2939)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

When pad-pak is inserted the device switches on automatically and will not switch off unless pad-pak is removed.There was no patient involved in this event.

Manufacturer Narrative

The device history records for the sam 350p device and pad-pak were reviewed and this confirmed that all manufacturing and quality checks and test had been successfully completed.The sam 350p passed ¿out qat from heartsine technologies on the (b)(6)2016.Upon investigation, the device was witnessed switching on automatically, confirming the reported fault.The fault was attributed to moisture and corrosion within the device, which was observed on many critical circuits and components, including the on_button line of the membrane tail.Additionally, the moisture observed on status led circuitry and membrane tail tracks had resulted in both status leds constantly illuminating alongside a constant beep.Furthermore, the returned pad-pak (expiry november 2020) was found to be depleted beyond any use.This was likely a further consequence of the constantly illuminated status leds and beep, which would have resulted in significant excess current drain.It is unclear when the moisture had initially penetrated the device.However, the corrosion observed on the membrane tail would indicate the device had been in the presence of moisture for a prolonged period of time.Advise user of the recommended storage conditions as detailed within the user manual as being located in a clean, dry environment at a temperature between 0 to 50°c and 5 to 95% relative humidity (non-condensing).It is a policy of heartsine to not refurbish devices that have been returned from the field, therefore this device shall be retained and replaced with a new sam 350p.

Event Description

When pad-pak is inserted the device switches on automatically and will not switch off unless pad-pak is removed.There was no patient involved in this event.

• Brand Name: PACKAGE,350P,PP03,INTL EN,350-BAS-UK-10
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED
• MDR Report Key: 8694986
• MDR Text Key: 147872889
• Report Number: 3004123209-2019-00218
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: M727SAM350P
• UDI-Public: M727SAM350P
• 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: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 80514-000139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1