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

Catalog Number CON-HL-90

Device Problems Display or Visual Feedback Problem (1184); Noise, Audible (3273)

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

Event Date 03/31/2022

Event Type  malfunction  

Event Description

It was reported that the pump was noisy and there were broken leds.No patient involvement was reported.

Event Description

Additional information received indicated that this device was found broken on the equipment rack.

Manufacturer Narrative

Device evaluation a sample was received to perform an investigation.A visual inspection of the returned device found a cracked enclosure, broken power switch and liquid crystal display (led).In addition, the main components and membrane switch were found disconnected from the printed circuit board (pcb).The front cover was removed for a visual inspection and the reported problem was confirmed.Led's were found broken.The cause of the problem was determined to be physical force to the led's and wear and tear to the pump.It was determined that the damage was caused by the user.No repair actions were taken.Due to the age and condition of the unit, it was scrapped.A device history record (dhr) review was not performed because the results of the complaint investigation did 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.No product information has been 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 dock; minneapolis, MN 55442
• MDR Report Key: 14166494
• MDR Text Key: 289736503
• Report Number: 3012307300-2022-06774
• 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
• Report Date: 06/10/2022

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 Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1