MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number CON-HL-90

Device Problem Failure to Calibrate (2440)

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

Event Date 02/23/2022

Event Type  malfunction  

Event Description

It was reported the device was unable to calibrate.No patient injury was reported.

Event Description

It was reported the device was unable to calibrate.No patient involved.

Manufacturer Narrative

Corrected data: event date updated.No patient involved.

Manufacturer Narrative

Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.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performed.Visual inspection found wear and tear damaged enclosure, front cover, plate clip, line cord, pole clamp, an outdated printed circuit board (pcb) and power switch.Functional testing found even though the pcb was old, the device was able to be calibrated contrary to the customer complaint.Device passed all functional testing, unable to replicate the reported issue.No problem found.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.D5 and e4 are unknown, no information provided to date.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; receiving; minneapolis, MN 55442
• MDR Report Key: 13951232
• MDR Text Key: 294054092
• Report Number: 3012307300-2022-05519
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001764
• 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: 08/30/2022

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 Model Number: CON-HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 08/04/2022; 08/04/2022
• Supplement Dates FDA Received: 05/12/2022; 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1