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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER S7-3T 21781A TEE PROBE ASSEMBLY

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PHILIPS ULTRASOUND, INC TRANSDUCER S7-3T 21781A TEE PROBE ASSEMBLY Back to Search Results
Model Number 989605406772
Device Problem Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Return of the suspect transducer is anticipated. Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
 
Event Description
A customer reported an s7-3t model transducer displaying a tip temperature of zero degrees celsius. The discovery was made during installation and there was no patient involvement.
 
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Brand NameTRANSDUCER S7-3T
Type of Device21781A TEE PROBE ASSEMBLY
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
paul corrigan
22100 bothell everett highway
bothell, WA 98021
4254877000
MDR Report Key8724407
MDR Text Key148926121
Report Number3019216-2019-00035
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K132304
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989605406772
Device Lot NumberB1ZD4C
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/30/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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