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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN, INC. BRAUN THERMOSCAN PRO 6000; THERMOMETER, ELECTRONIC, CLINICAL
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WELCH ALLYN, INC. BRAUN THERMOSCAN PRO 6000; THERMOMETER, ELECTRONIC, CLINICAL Back to Search Results
Model Number PRO 6000
Device Problem High Readings (2459)
Patient Problem No Code Available (3191)
Event Date 05/05/2019
Event Type  malfunction  
Event Description
Tympanic temperature was taken and shown to be elevated.Pt's skin was flushed.Blood cultures, ua, and cxr were performed based on the elevated temp.Later, the tympanic was noted to be reading high on every reading.A repeat temp of the pt showed the temp to be afebrile.Manufacturer response for tympanic thermometer, welch allyn (per site reporter).Spoke with welch allyn on the phone- they said they would be sending a replacement thermometer and they would like the broken one back for investigation.Awaiting on new thermometer to arrive.Received new thermometer, packaged this one up and will send back to exergen.
 
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Brand Name
BRAUN THERMOSCAN PRO 6000
Type of Device
THERMOMETER, ELECTRONIC, CLINICAL
Manufacturer (Section D)
WELCH ALLYN, INC.
4341 state street road
welch allyn inc. corporate headquarters
skaneateles falls NY 13153
MDR Report Key8832129
MDR Text Key152380104
Report Number8832129
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPRO 6000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/05/2019
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer07/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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