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

Lot Number 02GV2C

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The customer reported a partial loss of articulation with an s7-2 omni model transducer in use with an ie33 ultrasound system.The customer was provided with a quote for replacing the suspect transducer.However, the customer did not accept the quote for replacement and the transducer remains at the customer site.Since the device was not returned and a return is not expected, no device evaluation could be performed.

Event Description

A customer reported an s7-2 omni model transducer had a partial loss of articulation during use.There was no injury associated with this 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
• 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: 10088452
• MDR Text Key: 193131908
• Report Number: 3019216-2020-00028
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030455
• 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: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 02GV2C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2011
• 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