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

Model Number HL-90

Device Problem Defective Component (2292)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the unit was malfunctioning.There was a damaged hose detection latch.Patient involvement unknown.

Manufacturer Narrative

Other text: d4: udi number unknown, b3: date of event, no information provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Manufacturer Narrative

Other, other text: g1,2 email is: regulatory.Responses@icumed.Com.One device was received dirty.Per visual inspection, corroded quick connect, damaged pole clamp, faded line cord, cracked water tank cover, outdated printed circuit board (pcb) and power switch.Per functional testing, the device failed because the microswitch was bent.The complaint was confirmed.The root cause was a bent microswitch due to user interface from usage.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.No action taken due to the condition of the device.It was deemed beyond economical repair and was scrapped.

Event Description

Additional information received via email.Event occurred during preventive maintenance checkup.There was no patient injury.

• Brand Name: LEVEL 1 HOTLINE FLUID WAWRMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17638857
• MDR Text Key: 322152910
• Report Number: 3012307300-2023-08458
• 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: 12/01/2023

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: HL-90
• 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: 08/08/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1