MAUDE Adverse Event Report: ST PAUL LEVEL 1 IRRIGATION FAST FLOW; WARMER, THERMAL, INFUSION FLUID

Model Number H-1129

Device Problem Defective Device (2588)

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

Event Date 05/31/2022

Event Type  malfunction  

Event Description

It was reported that the pole will not raise and physical damage.

Event Description

Additional information was received which included the event date and that was no patient involvement.

Manufacturer Narrative

Corrected data: corrected h6.

Manufacturer Narrative

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: [3012307300-2022-12554].The report was submitted in error., corrected data: corrected information provided in h10.

• Brand Name: LEVEL 1 IRRIGATION FAST FLOW
• 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: 14827795
• MDR Text Key: 302579750
• Report Number: 3012307300-2022-12554
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2023

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: 06/02/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 06/29/2022; 02/09/2023
• Supplement Dates FDA Received: 07/22/2022; 06/01/2023
• 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