MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC S8-3T MICRO TEE TRANSDUCER

Model Number 989605420183

Device Problem Poor Quality Image (1408)

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 s8-3t model transducer was producing poor image quality.There was no injury associated with this event.

Manufacturer Narrative

The suspect transducer was inadvertently scrapped prior to its return to philips for evaluation.Therefore, no failure or root cause analysis of the device could be performed.The cause of the failure could not be determined.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 scrapped in the key market prior to return.

• Brand Name: S8-3T MICRO TEE TRANSDUCER
• Type of Device: S8-3T MICRO TEE TRANSDUCER
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 10390790
• MDR Text Key: 203337743
• Report Number: 3019216-2020-00054
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838067523
• UDI-Public: (01)00884838067523
• Combination Product (y/n): N
• PMA/PMN Number: K030455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

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: 989605420183
• Device Lot Number: B34PBT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1