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

Model Number HL-390

Device Problems Intermittent Loss of Power (4016); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Other text: b3: date of event 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 the device's power switch was faulty.When it was switched on it immediately turns off.If there is slight pressure on the switch it will stay on.Patient involvement is unknown.

Manufacturer Narrative

Email is: (b)(6).Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.The exact cause could not be determined; however, based on the reported problem, the most probable cause would be an outdated pcb board with a broken power switch leads connection to the board.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• 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: 17886653
• MDR Text Key: 325850971
• Report Number: 3012307300-2023-09563
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10695085002796
• UDI-Public: 10695085002796
• 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
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• 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: HL-390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1