MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, RED 350P, 1X PAD-PAK-03, GERMAN, 350-STR-ST-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number SAM 350P

Device Problems Device Alarm System (1012); Noise, Audible (3273)

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

Event Date 12/11/2020

Event Type  malfunction  

Event Description

Audible alarm, intermittent red led.No error displayed in the memory.No patient involvement.

Manufacturer Narrative

Red status led and beep confirmed upon receipt.Upon investigation the device indicated no failed self-tests.Measurements taken indicated a fault with mosfet q45, which forms part of the red status indicator logic circuitry, confirmed by replacement of the component and clearance of the fault.

Event Description

Audible alarm, intermittent red led.No error displayed in the memory.No patient involvement.

• Brand Name: PACKAGE, RED 350P, 1X PAD-PAK-03, GERMAN, 350-STR-ST-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: 11072019
• MDR Text Key: 224409585
• Report Number: 3004123209-2020-00396
• 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: 03/26/2021

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 Model Number: SAM 350P
• Device Catalogue Number: 350-STR-ST-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1