MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC; ULTRASOUND

Model Number 989605414121

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 articulation issue with their x7-2t model transducer.There was no injury associated with this event.

Manufacturer Narrative

A thorough evaluation of the x7-2t model transducer identified damage to the device.Visual inspection of this probe revealed several pin holes in the sheath, protein build up, chipped beading, a scratched i-tube, discolored cable jacket and dried fluid ingress in the connector.Further performance testing also found the steering cable ferrule had insufficient solder resulting in the failure to articulate in the anterior direction.The extensive physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.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.

• Type of Device: ULTRASOUND
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 8302901
• MDR Text Key: 135052347
• Report Number: 3019216-2019-00003
• Device Sequence Number: 1
• Product Code: ITX
• 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: 01/25/2019

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: 989605414121
• Device Lot Number: B1ZGKZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 01/25/2019
• Supplement Dates FDA Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1