MAUDE Adverse Event Report: NULL; BLOOD AND PLASMA WARMING DEVICE

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

One unit was returned for investigation.Visual inspection was done then the tank was filled with water and attached to the temp check.When turned on, the device ran for hours with no problems contrary to the customer complaint.Dhr was not done due to no fault being found.

Event Description

It was reported that there was a bad display.

• Type of Device: BLOOD AND PLASMA WARMING DEVICE
• Manufacturer (Section G): NULL
• MDR Report Key: 12555062
• MDR Text Key: 274044812
• Report Number: 3012307300-2021-09693
• Device Sequence Number: 1
• Product Code: BSB
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: No
• 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