MAUDE Adverse Event Report: MEDCARE MEDCARE STAND AND WEIGH

Model Number 400007

Device Problem Device Tipped Over (2589)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

The lift was inspected by the facility maintenance supervisor and found to be operating correctly.The last preventative maintenance performed on the device was in march 2015 and this is a first time occurrence for this type of incident.The lift is not being returned for evaluation.We reenacted how this could occur in several ways with similar results as what occurred in the facility following improper foot placement by not having both feet entirely on the loft.Therefore, we believe the patient was not standing with booth heels on the platform fully and caused the lift to tilt to one side.

Event Description

Lift tilted while in use with a patient.Facility reported the individual stepped on the edge of the platform causing it to tilt to one side.The facility indicated no injuries occurred to report.

• Brand Name: MEDCARE STAND AND WEIGH
• Type of Device: MEDCARE STAND AND WEIGH
• Manufacturer (Section D): MEDCARE; burnsville MN 55337
• Manufacturer Contact: steve kilburn ; 10888 metro ct; maryland heights, MO 63043 ; 3142198614
• MDR Report Key: 5011600
• MDR Text Key: 24112612
• Report Number: 3007802293-2015-00032
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Inspection
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 400007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• 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
• Patient Age: 54 YR
• Patient Weight: 122