MAUDE Adverse Event Report: ST PAUL ELECTRONIC ASSEMBLY - 115V TRAUMA FFW 1 EA; WARMER, THERMAL, INFUSION FLUID

Catalog Number 7012701

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Event Description

It was reported that the board is bad.No patient involvement.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.The technician performed visual inspection and pre-test.The technician installed main printed circuit board (pcb) onto a h-1200 test device.Powered on device and no heating.This confirmed customer reported problem.The root cause of the reported issue was found to be faulty main pcb.The technician sent a pcb for replacement.

Manufacturer Narrative

Additional information: d4 udi is unknown.No product information has been provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.The technician performed visual inspection and pre-test.The technician installed main printed circuit board (pcb) onto a h-1200 test device.Powered on device and no heating.This confirmed customer reported problem.The root cause of the reported issue was found to be faulty main pcb.The technician sent a pcb for replacement.

• Brand Name: ELECTRONIC ASSEMBLY - 115V TRAUMA FFW 1 EA
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14118475
• MDR Text Key: 289336904
• Report Number: 3012307300-2022-06439
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK940056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7012701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1