MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC MINI MULTI TEE PROBE

Lot Number 037FGM

Device Problem Difficult to Remove (1528)

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 difficulty removing a transducer following successful completion of a patient examination.There was no injury associated with this event.

Manufacturer Narrative

The suspect transducer was inadvertently scrapped prior to evaluation, therefore, no additional failure analysis can be performed.

• Brand Name: MINI MULTI TEE PROBE
• Type of Device: MINI MULTI TEE PROBE
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 7249915
• MDR Text Key: 99324313
• Report Number: 3019216-2018-00008
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 037FGM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1