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

Model Number HL-90

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Event Description

It was reported that the warmer display pot will not adjust to current temperature.No report of patient involvement.

Manufacturer Narrative

Other text: b3: date of event is unknown, no information has been provided to date.Udi section of d4 is unknown, no product information has been provided to date.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 received via email.The issues were found during preventive maintenance (pm).There was no patient involvement.

Manufacturer Narrative

Other text: b5 and h6.Health impact and evaluation codes: updated.

Manufacturer Narrative

Health impact, and evaluation codes: updated.One device was received with a cracked tank cover, corroded drain fitting, outdated printed circuit board (pcb) and power switch.The complaint was confirmed as functional testing showed the pot on the printed circuit board (pcb) used to adjust the temperature on the liquid crystal display (lcd) has been damaged.A root cause was customer damage as the liquid crystal display (lcd) pot was broken then glued back onto the printed circuit board (pcb).A device history record (dhr) review was not performed because the device is beyond a year from its manufacture date there was no indication of a manufacturing defect during the investigation.Service history review identified this device has not been in for service previously.No action taken due to the condition of the device.It is deemed beyond economical repair and will be scrapped.

• 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17011309
• MDR Text Key: 316027531
• Report Number: 3012307300-2023-05759
• 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: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1