MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC; ULTRASOUND

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.

• Type of Device: ULTRASOUND
• 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 Key: 7347901
• MDR Text Key: 103022164
• Report Number: 3019216-2018-00020
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K030455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605414121
• Device Lot Number: B16DMH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1