MAUDE Adverse Event Report: ST PAUL NORMOFLO IRRIGATION FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number H-1129

Device Problem Power Problem (3010)

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

Event Type  malfunction  

Event Description

It was reported that the button was not going up and down.

Event Description

Additional information was received which stated no patient was involved.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-09793.The report was submitted in error.

• Brand Name: NORMOFLO IRRIGATION FLUID WARMER
• 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: 14518989
• MDR Text Key: 292807894
• Report Number: 3012307300-2022-09793
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085812904
• UDI-Public: 50695085812904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2023

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: Health Professional
• Device Model Number: H-1129
• Device Catalogue Number: H-1129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 06/07/2022; 05/05/2023
• Supplement Dates FDA Received: 07/06/2022; 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1