MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER S7-3T; 21781A TEE PROBE ASSEMBLY

Model Number 989605439232

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

A customer reported an s7-3t model transducer had no articulation in any direction.There was no injury associated with this event.

Manufacturer Narrative

A field service engineer replaced the suspect transducer for the customer to resolve the articulation issue.The suspect transducer was inadvertently discarded prior to returning to philips for evaluation.Therefore, no failure or root cause analysis of the part could be performed.However, the ultrasound system has been returned to service with a replacement transducer with no similar issues reported.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.H3 other text: transducer was inadvertently scrapped prior to evaluation.

• Brand Name: TRANSDUCER S7-3T
• Type of Device: 21781A TEE PROBE ASSEMBLY
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 10221360
• MDR Text Key: 197667065
• Report Number: 3019216-2020-00038
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838067530
• UDI-Public: (01)00884838067530
• Combination Product (y/n): N
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

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
• Device Operator: Health Professional
• Device Model Number: 989605439232
• Device Lot Number: B25B9T
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 06/10/2020
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1