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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN INC. PRO 6000 W/SMALL CRADLE; THERMOMETER, ELECTRONIC, CLINICAL

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WELCH ALLYN INC. PRO 6000 W/SMALL CRADLE; THERMOMETER, ELECTRONIC, CLINICAL Back to Search Results
Model Number 06000-200
Device Problem Excessive Heating (4030)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2023
Event Type  malfunction  
Manufacturer Narrative
The braun/welch allyn thermoscan pro 6000 ear thermometer is indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment.The probe cover is used as a sanitary barrier between the infrared thermometer and the ear canal.To help ensure accurate temperature measurements, the sensor itself is warmed to a temperature close to that of the human body.When the braun/welch allyn thermoscan is placed in the ear, it continuously monitors the infrared energy until a temperature equilibrium has been reached and an accurate measurement can be taken.Hillrom/welch allyn¿s investigation of pro 6000 ¿hot tip¿ complaints confirmed that aggressive cleaning and decontamination practices can cause liquid ingress.Consequently, liquid ingress can adversely affect the temperature sensor causing the pro 6000 device to behave inconsistently and to overheat the speculum tip.It is believed that replication of the malfunction with the returned devices from the customer at the manufacturing site has not been possible as any fluid that may have ingressed had likely evaporated, therefore not showing the ¿hot tip¿ malfunction.Based on hillrom¿s ability to replicate the malfunction of a ¿hot tip¿ on new devices that can potentially go above the built in risk mitigations of a safety cut off that could potentially cause a more serious injury we have deemed this complaint to be reportable.
 
Event Description
The customer reported that the probe tip of their braun pro6000 overheated.There were no allegations of injury.This incident was captured under hillrom complaint ref # (b)(4).
 
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Brand Name
PRO 6000 W/SMALL CRADLE
Type of Device
THERMOMETER, ELECTRONIC, CLINICAL
Manufacturer (Section D)
WELCH ALLYN INC.
4341 state street
skaneateles falls NY 13153
Manufacturer Contact
frances coote
1069 state route 46 east
batesville, IN 47006
8129310130
MDR Report Key16386743
MDR Text Key309666740
Report Number1316463-2023-00020
Device Sequence Number1
Product Code FLL
UDI-Device Identifier00732094309003
UDI-Public732094309003
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/16/2023
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 Model Number06000-200
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/06/2023
Initial Date FDA Received02/16/2023
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 Reuse
Patient Sequence Number1
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