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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC; 21781A TEE PROBE ASSEMBLY
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PHILIPS ULTRASOUND, INC; 21781A TEE PROBE ASSEMBLY Back to Search Results
Lot Number B04H6K
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Customer reported articulation difficulty while using an s7-3t transducer.No injury associated with this event was reported.
 
Manufacturer Narrative
Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
 
Manufacturer Narrative
The transducer was evaluated by the vendor who determined residue ingress through a damaged sheath caused intermittent articulation issues.
 
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Type of Device
21781A TEE PROBE ASSEMBLY
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC
22100 bothell everett highway
bothell WA 98021
Manufacturer Contact
kim dashen
22100 bothell everett highway
bothell, WA 98021
4254877000
MDR Report Key4865005
MDR Text Key16185278
Report Number3019216-2015-00036
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132304
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 06/10/2015
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 Lot NumberB04H6K
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/10/2015
Initial Date FDA Received06/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2014
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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