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

Catalog Number HL-90-INT-230

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

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Date of event and udi section of device identification are unknown.No product 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 alarmed and it was broken at lcd screen.No clinical health symptoms reported for the patient, because there was no patient involved during this incident.

• 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): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16542053
• MDR Text Key: 311292181
• Report Number: 3012307300-2023-02444
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K911383
• 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
• Report Date: 03/14/2023

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 Catalogue Number: HL-90-INT-230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1