MAUDE Adverse Event Report: OAKDALE CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE; WARMER, THERMAL, INFUSION FLUID

Catalog Number HL-90-INT-230

Device Problem Failure to Calibrate (2440)

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

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

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 was out of specification, during annual preventive maintenance.The non-conforming device could not be used.No patient was involved.

Manufacturer Narrative

Event problem and evaluation codes: updated.Device evaluated by manufacturer: updated.Device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.The customer reported problem was not related to any previous repair.Visual inspection found the device in bad condition; tears and wear were found on the enclosure and the enclosure was broken underneath.There was no evidence of the error in the event history log.The customer reported problem was verified/duplicated.A defective microswitch and a damaged enclosure was found during the investigation, confirming the complaint.Replacing the microswitch and the enclosure would have corrected the issue.However, the device was scrapped.The root cause of the reported problem traced to user interface/customer damage.The product is beyond a year from manufacture date and there was no indication or evidence provided in the complaint of a manufacturing defect, so a device history record review was not performed.The service history review identified there was no indication or evidence provided in the complaint or service history of a service issue.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

• Brand Name: CONTINENTAL EUROPEAN 230 VOLT LEVEL 1 HOTLINE
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15754798
• MDR Text Key: 307027870
• Report Number: 3012307300-2022-26901
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HL-90-INT-230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1