MAUDE Adverse Event Report: MAQUET GMBH (MAQUET MEDICAL SYSTEMS USA ) MAQUET ALPHASTAR; TABLE, OPERATING-ROOM, AC-POWERED

Device Problem Unintended Movement (3026)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 05/19/2017

Event Type  malfunction  

Event Description

Following surgery, table was being returned to normal from reverse trendelenberg procedure.While pushing the level button, the table foot board moved past level position.The patient's feet were noted to be in an awkward position.The foot board was returned to level position.No injury was immediately noted.Following the procedure, the patient complained about bilateral foot pain.Radiology revealed a small, non-displaced fracture in the lower fibula on the right foot.No injury was noted to the left foot.The table was removed from service.

• Brand Name: MAQUET ALPHASTAR
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH (MAQUET MEDICAL SYSTEMS USA ); dennis genito; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 6826998
• MDR Text Key: 83876478
• Report Number: 6826998
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other