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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN, INC. WELCH ALLYN, INC.; THERMOMETER, ELECTRONIC, CLINICAL

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WELCH ALLYN, INC. WELCH ALLYN, INC.; THERMOMETER, ELECTRONIC, CLINICAL Back to Search Results
Model Number 901053
Device Problems Loss of Power (1475); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2020
Event Type  malfunction  
Event Description
Shuts off all the time and temp inaccurate.
 
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Brand Name
WELCH ALLYN, INC.
Type of Device
THERMOMETER, ELECTRONIC, CLINICAL
Manufacturer (Section D)
WELCH ALLYN, INC.
4341 state street road
skaneateles falls NY 13153
MDR Report Key10008951
MDR Text Key189322565
Report Number10008951
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 Risk Manager
Type of Report Initial
Report Date 04/21/2020
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 No Information
Device Model Number901053
Device Catalogue Number01692-000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/21/2020
Date Report to Manufacturer04/29/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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