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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC X7-2T TRANSDUCER (MTEE) TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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PHILIPS ULTRASOUND, INC X7-2T TRANSDUCER (MTEE) TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number 989605350451
Device Problems Crack (1135); Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Type  malfunction  
Manufacturer Narrative
A thorough evaluation of the x7-2t model transducer identified extensive damage to the device. The transducer examination noted a missing film used to protect the acoustic window, a damaged rtv bead, holes in the articulation cover to tip shell epoxy bead, and a cut in the articulation cover. The location and type of damage identified would allow for the ingress of amino acid protein based debris. The exact root cause of the damage could not be determined, however, these findings are indicative of improper handling and maintenance.
 
Manufacturer Narrative
Evaluation of the transducer and additional details from the incident will be included in a follow up report upon its return and investigation completion.
 
Event Description
A customer reported that a number of patients in the intensive care unit were found to have bacteria in their throat for a couple of days. The customer stated that the only common factor shared between these patients was the same x7-2t model transducer used in each of their exams suggesting bacterial contamination. An initial visual inspection under a microscope performed by the hospital¿s internal department of hygiene and infection prevention identified minute cracks in the transducer. The suspect transducer has been removed from service and was replaced with a new x7-2t model probe. No further information regarding patient condition could be obtained at this time.
 
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Brand NameX7-2T TRANSDUCER (MTEE)
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
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 Key6751625
MDR Text Key258035793
Report Number3019216-2017-00026
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K030455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 07/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989605350451
Device Lot NumberB02J3C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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