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

Model Number HL-90

Device Problem No Display/Image (1183)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that the screen to a smiths medical level 1 hotline blood and fluid warmer was noted to be black.There were no reported adverse effects.

Manufacturer Narrative

One fluid warmer was returned for evaluation.Visual inspection of the device found the enclosue stained in water tank, both covers were cracked and scratched, line cord was worn, and pole clamp was broken.Tank was filled with water and powered on., confirming the reported customer complaint.Damage was noted on lcd and pcb; problem source has been determined to be user interface.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• MDR Report Key: 10106419
• MDR Text Key: 193114208
• Report Number: 3012307300-2020-05380
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

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: No Information
• Device Model Number: HL-90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 06/01/2020
• Supplement Dates Manufacturer Received: 06/05/2020
• Supplement Dates FDA Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1