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

Model Number HL-90

Device Problem Failure to Calibrate (2440)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

Event Type  malfunction  

Event Description

It was reported the device had "temperature issues".Issue was found during preventive maintenance; no patient involved.

Manufacturer Narrative

Device evaluation- the device was returned for evaluation.The device was given functional testing and this showed the over temperature alarm was out of calibration.However the reported issue was not confirmed; the over temperature alarm was successfully calibrated.

Event Description

Additional information received via email 02-nov-2021: date of event updated, the reported issue did not occur while in use with a patient, and there was no adverse event.

Manufacturer Narrative

Other, other text: additional:d4 udi is unknown.No product information has been provided to date.B5,, d5, h6.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No manufacturing or service issues were identified as causes of the customer's reported problem during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Device was received in with a cracked enclosure underneath the drain fitting, contained old style printed circuit board (pcb), drain fitting, and line cord.The enclosure has normal wear and tear.The technician attempted to calibrate with temperature check e5768 due (b)(6) 2022.The reported issue was not confirmed.The overtempt pot r106 was raised extremely high, but managed to perform calibration.The root cause of the reported issue was found to be the technician or users inability to perform calibration.No action taken due to the age and condition.Unit will be scrapped.

Event Description

Additional information received via email 02-nov-2021: date of event updated, the reported issue did not occur while in use with a patient, and there was no adverse event.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No manufacturing or service issues were identified as causes of the customer's reported problem during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.Device was received in with a cracked enclosure underneath the drain fitting, contained old style printed circuit board (pcb), drain fitting, and line cord.The enclosure has normal wear and tear.The technician attempted to calibrate with temperature check e5768 due (b)(6) 2022.The reported issue was not confirmed.The overtempt pot r106 was raised extremely high, but managed to perform calibration.The root cause of the reported issue was found to be the technician or users inability to perform calibration.No action taken due to the age and condition.Unit 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): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 777 bannock st; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 12763089
• MDR Text Key: 280473634
• Report Number: 3012307300-2021-10802
• 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: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/06/2023

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-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 11/23/2021; 02/03/2023; 02/03/2023
• Supplement Dates FDA Received: 12/22/2021; 03/03/2023; 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1