MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 EQUATOR BLOWER; SYSTEM, THERMAL REGULATING

Catalog Number CON-EQ-5000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Type  malfunction  

Event Description

It was reported that the level 1 equator blower had a bad lcd screen.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

Cover page was updated with correct hazard code as wrong product was reported.Convective warming|level 1 equator blowers not level one warming.

Event Description

Complaint of bad lcd was on convective warming|level 1 equator blowers not level one warming devices.Corrected cover page hazard code.

• Brand Name: LEVEL 1 EQUATOR BLOWER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 11664281
• MDR Text Key: 245351019
• Report Number: 3012307300-2021-03105
• Device Sequence Number: 1
• Product Code: DWJ
• 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: 05/28/2021

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-EQ-5000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1