MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ 7C - 795201; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22

Model Number EPIQ 7C - 795201

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Muscle Weakness (1967); Tingling (2171); Injury (2348)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

Initial visual inspection by the philips field service engineer identified the bushing in the swivel mechanism to be in an incorrect position.Evaluation of the control panel arm will be included in a follow up report upon its return and investigation completion.

Event Description

A customer reported a sonographer was injured while transporting the epiq ultrasound system to the echo lab.Feedback details described the incident as occurring when the swivel mechanism on the control panel arm came loose during transport.The sonographer was seen in the er and her injuries included a back muscle strain and weakening and tingling down her arm.After several attempts, no additional details regarding the patient injury or medical intervention could be obtained.The system remains at the site and was returned to service following the replacement of the control panel arm.

Manufacturer Narrative

A thorough investigation of the control panel arm assembly was performed which included an engineering evaluation of the swivel mechanism bushing moving out of position.The displaced bushing prevented the control panel from locking properly.The evaluation determined the ultrasound system did not have loctite on the swivel mechanism bushing to prevent movement over time.The inclusion of applying loctite to the swivel mechanism bushing during assembly has been implemented to reduce the probability of future recurrence.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: EPIQ 7C - 795201
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 9835570
• MDR Text Key: 183550816
• Report Number: 3019216-2020-00019
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K160807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EPIQ 7C - 795201
• Device Catalogue Number: EPIQ 7C - 795201
• Device Lot Number: US514B0367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization