MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC CLEARVUE 550 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22

Model Number 795094

Device Problem Component Falling (1105)

Patient Problem Bruise/Contusion (1754)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A customer reported a clearvue 550 ultrasound system's articulating arm fell on a patient during clinical use.The patient suffered a minor bruise and no additional medical intervention was required.The procedure in progress was completed successfully using another ultrasound system already available at the customer site.

Manufacturer Narrative

Evaluation of the articulating arm found the arm was improperly assembled.Design improvements were implemented to improve assembly process and enhance rotational torque.

• Brand Name: CLEARVUE 550 ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22
• 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: tara mackinnon ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 5391588
• MDR Text Key: 36986400
• Report Number: 3019216-2016-00005
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K120321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 795094
• Device Lot Number: US91290099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2012
• 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