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

Catalog Number CON-HL-90

Device Problem Power Problem (3010)

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

Event Type  malfunction  

Event Description

Information received a smiths medical warming|level 1 hotline low flow systems - hl-90 had no power.No further information.

Manufacturer Narrative

Device evaluation- the device was returned for evaluation.Examination showed the device had cracked casing and damage to circuit board and power switch during testing the reported issue was confirmed; device did not power on.The issue was determined caused by damage to connection between printed circuit board and power switch.These components were from an older iteration that is no longer used in servicing; these components have since been updated.

Manufacturer Narrative

Additional d5, g5, d4 udi is unknown.No product information has been provided to date.This mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.Cracked enclosure and tank cover.Old style printed circuity board (pcb) and power switch which is also damaged.Worn and faded line cord.The technician plugged line cord into power source and turned power switch on.No power.Removed front cover and printed circuit board (pcb) to investigate further.The reported problem was confirmed.The root cause of the reported issue was found to be normal wear by customer's daily use.No action taken due to the age and condition of the device.It is deemed beyond economical repair and will be scrapped.No causes or potential causes of the customer's reported problem were found during the review of service and repair records., corrected data: corrected d1 d2 d3 g1 h3 h6.

• 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; minneapolis, MN 55442
• MDR Report Key: 12350571
• MDR Text Key: 267562135
• Report Number: 3012307300-2021-08693
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 001764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2023

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 Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 11/09/2021; 02/01/2023
• Supplement Dates FDA Received: 12/10/2021; 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/1997
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1