MAUDE Adverse Event Report: DRAEGERWERK AG & CO. KGAA DRAGER RADIANT WARMER BED TEMPERATURE PROBE; THERMOMETER, ELECTRONIC, CLINICAL

Device Problem Low Readings (2460)

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

Event Date 12/24/2021

Event Type  No Answer Provided  

Event Description

Noticed infant was warm in afternoon care.Rn tried to wean the bed temperature down.Infant was warmer at next care time.Rn attempted to wean bed temperature a second time.Rn checks temp an hour later, temperature is 101.4 and temp probe is on correctly but reading cold and bed is at highest heat intensity.Product saved for products nurse.Manufacturer aware of issue.New probe used, issue did not repeat.

• Brand Name: DRAGER RADIANT WARMER BED TEMPERATURE PROBE
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA; 3135 quarry road; telford PA 18969
• MDR Report Key: 13691863
• MDR Text Key: 286745316
• Report Number: 13691863
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/22/2022

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1