MAUDE Adverse Event Report: INVIVO CORPORATION; NOT DETERMINED

Lot Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

The investigation of this event is ongoing, final investigation results will be communicated at a later date.

Event Description

A ge healthcare fse was moving a sentinelle table when his hand had become wedged between the table handle and the door frame.The door frame happen to have shard edges causing an incision in his hand which required stitches to correct.

Manufacturer Narrative

The service fsr was moving a vanguard table out of an mr room when his hand became caught between the table and the mr room door frame.User guides for vanguard tables reference that there is a risk to operator injury.The warning states ¿keep limbs away from the gap between the tabletop and the scanner while raising and lowering the mr patient table.¿ the same principle would apply when moving the table, i.E limbs should be kept away from the gap between the tabletop and other surfaces.Due to the weight of the table, it should be manipulated slowly to avoid it swinging.Ge communicated the incident to their field engineers to be aware of the potential for injury if a body part is caught between the table and mr room door frame.This is the first complaint for this type is failure; therefore, no design change is warranted at this time.

• Type of Device: NOT DETERMINED
• Manufacturer (Section D): INVIVO CORPORATION; 3545 sw 47th ave; gainsville FL 32608
• Manufacturer (Section G): PHILIPS HEALTHCARE - INVIVO DIAGNOSTIC IMAGING; 3545 sw 47th ave; gainesville FL 32608
• Manufacturer Contact: kenneth revennaugh ; 3545 sw 47th ave; gainsville, FL 32608
• MDR Report Key: 5923022
• MDR Text Key: 53782214
• Report Number: 1056069-2016-00002
• Device Sequence Number: 1
• Product Code: MOS
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention