MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC S7-2 OMNI - 21778A; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 989605440772

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.

Event Description

A customer reported an s7-2 omni model transducer would not articulate during use.There was no injury associated with this event.

Manufacturer Narrative

Evaluation of the transducer confirmed the articulation issue as described by the customer.Functional testing of the device noted failure of the articulation test.Visual inspection noted damage to the connector, window, and i-tube.The transducer was then inadvertently scrapped prior to destructive testing by the vendor.Although the cause of the articulation issue could not be determined, the 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.

• Brand Name: S7-2 OMNI - 21778A
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 10176521
• MDR Text Key: 196396919
• Report Number: 3019216-2020-00034
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838067646
• UDI-Public: (01)00884838067646
• 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: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605440772
• Device Lot Number: 03C9R5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1