MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC S7-3T - 989605406771; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	989605406772
Health Effect - Clinical Codes	Death (1802); Perforation of Esophagus (2399)
Type of Reportable Event	Death
Additional Manufacturer Narrative
The field service engineer tested the suspect transducer at the customer site and the transducer passed all functional and diagnostic testing.The transducer return is anticipated and a complete evaluation of the device will be included in a follow-up report upon its return and investigation completion.
Event or Problem Description
A customer reported an s7-3t model transducer perforated a neonatal esophagus while undergoing heart surgery.During the procedure the patient expired.
Additional Manufacturer Narrative
Evaluation of the returned device confirmed the tee transducer had a swollen sheath, a worn and scratched handle, residue on the cable jacket, and scratches on the tip shell.The swollen sheath was determined to be caused by chemical damage and is mitigated by following documented instructions for safe use and proper cleaning.Further information from the physician involved in the event confirmed the transducer was not the cause of death.The patient¿s death was due to very severe vascular malformations in the heart, which were incompatible with a survivable prognosis.The laceration in the esophagus caused by the tee transducer was repaired by a pediatric surgeon.

• Brand Name: S7-3T - 989605406771
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 7709994
• Report Number: 3019216-2018-00039
• Device Sequence Number: 11455998
• Product Code: ITX
• UDI-Device Identifier: 00884838061439
• UDI-Public: (01)00884838061439
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K043535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 989605406772
• Device Lot Number: B210BC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death