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

Model Number HL-90

Device Problems No Audible Alarm (1019); No Audible Prompt/Feedback (2282)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Other text: b3: date of event and d4: udi number is unknown; no information has been 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 additional reportable information becomes available.

Event Description

It was reported that there was no audio.The lights come on but no audio during start up.Patient involvement unknown.

Manufacturer Narrative

G1,2 email is: regulatory.Responses@icumed.Com.One device was received in poor condition.Per visual inspection, the front cover and enclosure both had multiple scratches and nicks in the paint, pole clamp had scratches, water tank was contaminated with rust and the water tank cover was cracked, line cord faded and worn, microswitch was bent, there was a crack in the enclosure, under the quick connect, quick connect was corroded.Per functional testing, the lights came on, but no alarm sounds.The complaint was confirmed.The root cause was a faulty printed circuit board (pcb) board with no audible speaker alarm.It was unknown what caused it to become faulty.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.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• 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: 18041916
• MDR Text Key: 326993474
• Report Number: 3012307300-2023-10071
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• 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?: No
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1