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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WELCH ALLYN INC. PRO6000 BULK PACK, WA; THERMOMETER, ELECTRONIC, CLINICAL
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WELCH ALLYN INC. PRO6000 BULK PACK, WA; THERMOMETER, ELECTRONIC, CLINICAL Back to Search Results
Model Number 419712
Device Problems Overheating of Device (1437); Excessive Heating (4030)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2021
Event Type  malfunction  
Manufacturer Narrative
The braun 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.Hillrom would need to investigate further the device reported by the customer.The thermometer has not yet been returned by the customer.Hillrom is attempting to obtain the device from the customer and will determine if this is a reportable event under current regulations once the full investigation has been completed by the manufacturer.No further information is available on the investigation of the device at this time.The investigation is ongoing and any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a final report.
 
Event Description
The customer reported that their thermometer is overheating.The customer tested the temperature of the device and stated that it is reaching 60 degrees celsius/140 degrees fahrenheit.There was no report of injury or death.This report was filed in our complaint handling system as complaint # (b)(4).
 
Event Description
The customer reported that their thermometer is overheating.The customer tested the temperature of the device and stated that it is reaching 60 degrees celsius/140 degrees fahrenheit.There was no report of injury or death.This report was filed in our complaint handling system as complaint # (b)(4).
 
Manufacturer Narrative
The customer reported that their thermometer is overheating.The customer tested the temperature of the device and stated that it is reaching 60oc.There was no report of injury or death.The braun thermoscan® pro 6000 ear thermometer is indicated for the intermittent measurement of human body temperature.The device was returned by the customer on (b)(6) 2021.The device was preliminarily inspected by the hillrom service technicians and the following was concluded: the device has physical damage to the tip; the perfectemp sensor system is not functioning or disabled icon in the display; the malfunction of hot probe tip could not be reproduced.The device was then returned to the manufacturing site for a thorough investigation.The hillrom manufacturing site was not able to reproduce the malfunction on the device.However, the hillrom manufacturing site has recently been able to reproduce the hot probe tip malfunction, with new devices, when the devices are subjected to various cleaners in an aggressive cleaning simulation.It is believed that replication of the malfunction with the returned device 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.
 
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Brand Name
PRO6000 BULK PACK, WA
Type of Device
THERMOMETER, ELECTRONIC, CLINICAL
Manufacturer (Section D)
WELCH ALLYN INC.
4341 state street
skaneateles falls NY 13153
MDR Report Key11301102
MDR Text Key241023894
Report Number1316463-2021-00001
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 04/28/2021
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 No Information
Device Model Number419712
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/12/2021
Initial Date FDA Received02/09/2021
Supplement Dates Manufacturer Received01/12/2021
Supplement Dates FDA Received04/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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