MAUDE Adverse Event Report:; BLOOD AND PLASMA WARMING DEVICE

Model Number CON-HL-390

Device Problem Failure to Power Up (1476)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

One unit was returned for investigation.Visual inspection was done followed by physical inspection.Tank was filled with water and temp check was attached.Temperature was intermittent and would not stabilize.The customer complaint was confirmed.The pcb board was replaced.Dhr review was not done due to investigation not indicating a problem with the manufacturing of the device.No root cause analysis could be confirmed.

Event Description

It was reported that the unit wasn't powering on.

• Type of Device: BLOOD AND PLASMA WARMING DEVICE
• MDR Report Key: 12514102
• MDR Text Key: 273761789
• Report Number: 3012307300-2021-09543
• 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
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CON-HL-390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1