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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC ULTRASOUND

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PHILIPS ULTRASOUND, INC ULTRASOUND Back to Search Results
Model Number 989605414121
Device Problem Microbial Contamination of Device (2303)
Patient Problem Unspecified Infection (1930)
Event Date 01/15/2018
Event Type  Death  
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 an enterobacteria contamination was found in their icu department. The site¿s internal department for the prevention of infectious diseases identified an x7-2t model transducer as a possible cause of the infection. An initial visual inspection by the site noted a small part of the device¿s rtv bead was missing. The suspect transducer has been removed from service. No further information regarding patient condition could be obtained at this time.
 
Manufacturer Narrative
Further investigation revealed an enterobacter cloacae outbreak at this hospital was reported to the agency of care and health on (b)(6) 2017 and the (b)(6) on (b)(6) 2018. Additional information obtained for this incident exposed a patient death occurred as a direct result of this bacterial contamination after undergoing several examinations with various transesophageal (tee) transducers in both the operating room and intensive care unit. The customer could not confidently identify which transducer(s) were contaminated. The customer has retained the suspect x7-2t transducer and will use protective sleeves to reduce the likelihood of contamination. Since the device was not returned for evaluation and a return is not anticipated, no failure analysis can be performed. The customer could not confidently identify which transducer(s) were contaminated. The customer has retained the suspect x7-2t transducer and will use protective sleeves to reduce the likelihood of contamination. Since the device was not returned for evaluation and a return is not anticipated, no failure analysis can be performed.
 
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Type of DeviceULTRASOUND
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 Key7347901
MDR Text Key103022164
Report Number3019216-2018-00020
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 Other
Type of Report Initial,Followup
Report Date 02/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989605414121
Device Lot NumberB16DMH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2014
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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