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

Catalog Number CON-HL-90

Device Problem Display Difficult to Read (1181)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

One fluid warmer was received for evaluation.Visual inspection of the device was found to have wear and tear damage.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.Device underwent functional testing, confirming the reported customer complaint.This was a result of a faulty pcb with an unknown problem source.

Event Description

Information was received device suspected to have a bad led display.No adverse effects reported.

• Brand Name: LEVEL 1
• Type of Device: HOTLINE LOW FLOW SYSTEM
• Manufacturer (Section G): NULL
• MDR Report Key: 11262555
• MDR Text Key: 229805278
• Report Number: 3012307300-2021-00752
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• 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: 01/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2015
• 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