FDA Adverse Event
Death
Summary report: N
X7-2T TRANSDUCER (MTEE) COMPACT
MDR report key: 6041902
·
Received October 19, 2016
Report
- Report Number
- 3019216-2016-00040
- Event Type
- Death
- Date Received
- October 19, 2016
- Report Date
- October 11, 2016
- Manufacturer
- PHILIPS ULTRASOUND, INC
- Product Code
- ITX
- PMA / PMN Number
- K123754
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION OF THE TRANSDUCER WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS RETURN AND INVESTIGATION COMPLETION.
Additional Manufacturer Narrative · 1
EVALUATION OF THE TRANSDUCER FOUND A LARGE HOLE IN THE BENDING NECK SHEATH WHICH ALLOWED FLUID AND DEBRIS INGRESS. THIS DAMAGE IS INDICATIVE OF IMPROPER HANDLING AND MAINTENANCE. A BIOLOGICAL EVALUATION OF THE TRANSDUCER FOUND NO HARMFUL BACTERIA PRESENT AT THE TIME OF TESTING.
Description of Event or Problem · 1
A CUSTOMER REPORTED CROSS CONTAMINATION OF AN X7-2T MODEL TRANSDUCER IN THE CARDIAC SURGERY UNIT CAUSED A BACTERIAL INFECTION RESULTING IN PATIENT DEATH(S). AN INITIAL VISUAL INSPECTION AND SAFETY TEST OF THE DEVICE RESULTED IN NO DETECTED PROBLEMS. THE SUSPECT TRANSDUCER HAS BEEN REMOVED FROM SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 690360 | X7-2T TRANSDUCER (MTEE) COMPACT | TRANSDUCER, ULTRASONIC, DIAGNOSTIC | ITX | PHILIPS ULTRASOUND, INC | 989605361911 | B0WTX3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |