MAUDE Adverse Event Report: NULL LEVEL 1; HOTLINE FLUID WARMER LOW FLOW SYSTEM

Catalog Number CON-HL-90

Device Problem Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received that device doesn't turn on at all.No adverse effects reported.

• Brand Name: LEVEL 1
• Type of Device: HOTLINE FLUID WARMER LOW FLOW SYSTEM
• Manufacturer (Section G): NULL
• MDR Report Key: 10520781
• MDR Text Key: 206500029
• Report Number: 3012307300-2020-09220
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 09/11/2020

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/1997
• 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