MAUDE Adverse Event Report: OAKDALE LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID

Model Number HL-390

Device Problems Device Alarm System (1012); No Display/Image (1183)

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

Event Type  malfunction  

Event Description

It was reported that the display would not work and it gave no alarms but you could "hear pump run".Patient involvement unknown.

Manufacturer Narrative

Date of event and 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 received: device was in storage and found during annual inspection.No patient harm.

Manufacturer Narrative

Other text: additional information - b5 and h6 updated.

Manufacturer Narrative

H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received.Visual inspected noted a cracked enclosure and broken front cover, worn block assembly and faded line cord.Filled tank with water, attached temperature check, plugged in line cord, and turned on the power switch for functional tests.The display is blank and none of the alarms work when triggered confirming the customer complaint.A root cause was due to a faulty printed circuit board (pcb).A device history record (dhr) review was not performed because the device is beyond a year from its manufacture date and there was no indication of a manufacturing defect during the investigation.Service history review identified this device has not been in for service in the previous 12 months and there was no indication that the complaint was related to a previous service of the device.The existing printed circuit board (pcb) was swapped out for a new one and the liquid crystal display (lcd) worked, and the alarms went off when triggered.No further action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.

• Brand Name: LEVEL 1 HOTLINE FLUID WARMER, 390
• 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: 16811352
• MDR Text Key: 314000082
• Report Number: 3012307300-2023-04546
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• 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: 08/14/2023

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-390
• Device Catalogue Number: CON-HL-390
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: 05/25/2023; 07/26/2023
• Supplement Dates FDA Received: 06/05/2023; 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1