MAUDE Adverse Event Report: G.E MEDICAL SYSTEMS ISRAEL LTD. VIVID Q; VIVID Q W/SAFELOCK CART

Model Number 5412203/H45021CR

Device Problems Component Falling (1105); Device Handling Problem (3265)

Patient Problem Laceration(s) (1946)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

Patient information not provided because no patient was involved.The initial reporter is located outside the u.S., and therefore customer contact information is not provided due to country privacy laws.Ge healthcare's investigation is ongoing.A follow-up report will be submitted when the investigation is complete.Device evaluation anticipated, but not yet begun.

Event Description

While transporting a vivid-q ultrasound system attached to a safelock cart up an incline a user received two lacerations which required sutures, one on each shin, due to the cart falling over.

Manufacturer Narrative

Additional information was received and ge¿s investigation is complete.The customer reported that two physicians were involved in transporting the ultrasound unit when the incident occurred.One was pulling the rear handle on the cart, and the other was pushing from the front hand rest on the cart.They were moving up an incline when they encountered an uneven surface and both the cart and the person pushing toppled over.The person pulling was able to avoid injury, and the person pushing fell onto the cart and sustained the injuries.Device evaluated by mfr: updated.Ge¿s investigation concluded there was no malfunction involved, the design provides sufficient stability, there is no trend of incidents of this type, and it confirmed that instructions say to push the cart from the rear handle.The customer was guided through instructions for pushing the cart from the rear handle as a correction.

• Brand Name: VIVID Q
• Type of Device: VIVID Q W/SAFELOCK CART
• Manufacturer (Section D): G.E MEDICAL SYSTEMS ISRAEL LTD.; 4 etgar street; tirat carmel ; IS
• Manufacturer Contact: joseph tamblyn ; 9900 w. innovation dr.; mail drop: rp-2138; wauwatosa, WI
• MDR Report Key: 6681024
• MDR Text Key: 78823146
• Report Number: 9615849-2017-00001
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K121062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5412203/H45021CR
• Device Lot Number: 056234VQ/CP11451
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other