MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC Transducer X8-2t

Model Number 989605455171

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The customer has continued using this transducer with no further issues and has declined a transducer replacement.Since a return of the transducer is not expected, no additional device analysis can be performed.

Event Description

A customer reported encountering an articulation issue with their x8-2t model transducer during a tee examination.There was no injury associated with this event.

• Brand Name: Transducer X8-2t
• Type of Device: TRANSDUCER
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: paul corrigan ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 9176705
• MDR Text Key: 175914980
• Report Number: 3019216-2019-00069
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838069718
• UDI-Public: (01)00884838069718
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/10/2019

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
• Device Operator: Health Professional
• Device Model Number: 989605455171
• Device Lot Number: B2GCZM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1