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

Model Number	989605406772
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return of the suspect transducer is anticipated.Evaluation of the transducer 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 displaying a tip temperature of zero degrees celsius.The discovery was made during installation and there was no patient involvement.
Event or Problem Description
A customer reported an s7-3t model transducer displaying a tip temperature of zero degrees celsius.The discovery was made during installation and there was no patient involvement.3019216-2019/08/28-002-r.
Additional Manufacturer Narrative
A thorough investigation was performed to determine the root cause of the reported issue.The investigation determined a small number of s7-3t and s8-3t model transducers were not properly programmed during manufacturing which can result in an incorrect distal tip temperature.A notice was sent to all customers regarding this programming error.All affected transducers are being replaced to resolve this issue.This action was reported to fda per 21 cfr part 806 on 8/28/2019.Reference corrections and removal report number 3019216-2019/08/28-002-r.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• 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: 8724809
• Report Number: 3019216-2019-00038
• Device Sequence Number: 19400913
• Product Code: ITX
• UDI-Device Identifier: 00884838061439
• UDI-Public: (01)00884838061439
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 989605406772
• Device Lot Number: B2HX44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1