MAUDE Adverse Event Report: ST PAUL LEVEL 1 FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number 8002950

Device Problems Temperature Problem (3022); Complete Loss of Power (4015)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2020

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical device over heats and shuts off.The device was constructed and then overheated on power up.No patient present at the time of the event.No reported adverse events.

Manufacturer Narrative

Other, other text: h10 device evaluation results: one level 1 trauma fast flow system was returned for investigation in used condition.The investigation revealed that the device was overheating and shutting off.The customer reported product problem was therefore confirmed.The problem occurred due to a faulty main pcb.A determination was not made on how the pcb became faulty.A root cause was not established.

• Brand Name: LEVEL 1 FLUID WARMER
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11070108
• MDR Text Key: 223602084
• Report Number: 3012307300-2020-12569
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: 50695085829506
• Combination Product (y/n): N
• PMA/PMN Number: BK020043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8002950
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1