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

Model Number HL-90

Device Problems Electrical /Electronic Property Problem (1198); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/26/2023

Event Type  malfunction  

Event Description

It was reported that the device electrical safety failed.Patient involvement unknown.

Manufacturer Narrative

Other, other text: 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

Additional information was received: event occurred during preventive maintenance.No medical intervention was required but is still ongoing.Relevant tests or laboratory data: "multiple tests run with esa, ground wire resistance was consistently above 0.5 ohms, which is our standard".

Manufacturer Narrative

Other, other text: additional information: a1.B5 and h6 - health effects codes.

Manufacturer Narrative

Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Email is: (b)(4).One device was received.Per visual inspection, old, faded line cord, out dated front cover, out dated printed circuit board (pcb) and power supply, corroded quick connect, corroded thermistor, enclosure had multiple nicks and scratches, water tank cover was cracked on all four corners, inside water tank was rust contamination.Per functional testing, the device did not pass electrical safety.The complaint was confirmed.The root cause was a bent micro switch, it was unknown what caused the condition.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: 18007587
• MDR Text Key: 326848678
• Report Number: 3012307300-2023-09917
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1