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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC S7-3T - 989605406771 TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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PHILIPS ULTRASOUND, INC S7-3T - 989605406771 TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number 989605406772
Device Problems Detachment Of Device Component (1104); Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
 
Event Description
A customer reported that while performing a procedure with an s7-3t model transducer, a portion of the probe¿s tip cracked and the bending neck sheath began to detach from the device. The transducer was promptly removed from the patient¿s throat with no part of the probe remaining in the patient. The site¿s philips field service engineer confirmed there were no injuries associated with this event. The suspect transducer has been removed from service and will be returned for evaluation.
 
Manufacturer Narrative
Evaluation of the transducer confirmed the condition as described by the customer. The investigation noted damage to the probe tip and control handle, a swollen sheath, fluid ingress in the connector, blue ink on the strain relief, cracked beading, and dead elements with the array. The failure analysis concluded the extensive physical damage to the device was caused by improper chemical exposure from the site.
 
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Brand NameS7-3T - 989605406771
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC
22100 bothell everett highway
bothell WA 98021
MDR Report Key7339526
MDR Text Key102588255
Report Number3019216-2018-00019
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K043535
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 03/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989605406772
Device Lot NumberB1VZRN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

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