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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS REUSABLE ESOPHAGEAL/RECTAL TEMPERATURE PROBE, INFANT
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PHILIPS MEDICAL SYSTEMS REUSABLE ESOPHAGEAL/RECTAL TEMPERATURE PROBE, INFANT Back to Search Results
Model Number 21076A
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Unable to confirm serial number.A follow-up report will be submitted once the investigation is complete.
 
Event Description
The customer reported that the plastic piece is broken of the temperature probe.The device was in use on a patient.There was no report of patient or user harm.
 
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Brand Name
REUSABLE ESOPHAGEAL/RECTAL TEMPERATURE PROBE, INFANT
Type of Device
NA
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key10143506
MDR Text Key195236192
Report Number1218950-2020-03390
Device Sequence Number1
Product Code FLL
UDI-Device Identifier00884838001008
UDI-Public(01)00884838001008
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K962070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/29/2020
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 Health Professional
Device Model Number21076A
Device Catalogue Number989803100891
Device Lot Number19-95728
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/29/2020
Initial Date FDA Received06/11/2020
Supplement Dates Manufacturer Received05/29/2020
Supplement Dates FDA Received07/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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