MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD HEARTSINE SAMARITAN 350P AND PAD-PAK; AUTOMATED EXTERNAL DEFIBRILLATOR

Catalog Number UNK_BEL

Device Problems Low Battery (2584); Defective Device (2588); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device not recieved yet.

Event Description

There was no patient involved.Enduser alleges that sam350p unit has low battery warning with pad pak installed expiry 2020 ; non fsca.

Manufacturer Narrative

A visual inspection of the device revealed that there was evidence of corrosion on the brass casing of the +ve battery terminal pogo pin and the usb contact collars.This would indicate the device had been subject to storage outside of the indicated conditions.The history log for this device showed that the pad-pak was first installed on the (b)(6) 2015 and performed to specification up to the (b)(6) 2018.The history log from the device shows the device failed self-tests due to a low battery between the (b)(6) 2018 and the (b)(6) 2018.The user would have been alerted with a ¿warning low battery, device service required¿ prompt and a flashing red status led and a failure chirp, as per the reported fault.The returned pad-pak was dissembled to investigate with five cells measuring approximately 3v and one cell measuring 0v.This would account for the low battery fails at the end of the history log would confirm the reported fault.The corrosion observed on the screws, usb contact collars and the brass casing of the +ve pogo pin would indicate the returned sam pad device had been subject to storage outside the indicated conditions.No evidence of storage outside the indicated conditions could be seen on the pad-pak but due to corrosion observed on the device it is assumed that the pad-pak had been stored along with the device and therefore resulted in the failed cell in the returned pad-pak.It is the policy of heartsine not to refurbish devices which have been returned from the field, after investigation, therefore this device shall be scrapped and replaced with another device of the same model.

Event Description

There was no patient involved.End user alleges that sam350p unit has low battery warning with pad pak installed expiry 2020; non fsca.

• Brand Name: HEARTSINE SAMARITAN 350P AND PAD-PAK
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED
• Manufacturer (Section G): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED
• Manufacturer Contact: caroline kirwan ; 203 airport road west; belfast BT3 9-ED ; 2890939400
• MDR Report Key: 7577341
• MDR Text Key: 110532304
• Report Number: 3004123209-2018-00377
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: M727SAM350P
• UDI-Public: M727SAM350P
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_BEL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 08/27/2018
• Supplement Dates FDA Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1