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

Model Number SAM 350P

Device Problems Unintended Power Up (1162); Self-Activation or Keying (1557); Data Problem (3196)

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

Event Date 02/05/2021

Event Type  malfunction  

Event Description

Device switching on automatically, memory full.No patient involvement.

Event Description

Device switching on automatically, memory full.No patient involvement.

Manufacturer Narrative

Membrane tail corrosion due to storage outside of the indicated conditions.Corrosion on the membrane tail between tracks 13 (on_button) and 14 (key3_button), which had created a partial short between these lines and multiple 10-minute timeouts in the history log, resulting in memory full prompts from the (b)(6) 2020, as per the reported fault.

• Brand Name: PACKAGE, 350P,1X PAD-PAK-03, DUTCH, 350-STR-NL-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: 11391459
• MDR Text Key: 238688344
• Report Number: 3004123209-2021-00070
• 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: 05/18/2021

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-NL-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1