MAUDE Adverse Event Report: DETECTO DETECTO IN-BED SCALE

Model Number IB600

Device Problems Mechanical Problem (1384); Device Tipped Over (2589)

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

Event Date 06/09/2016

Event Type  Injury  

Event Description

When attempting to weigh the patient on the lift weight scale, the lock on the leg supports unhitched causing the legs of the scale to move to the center and the scale tipped over to the side.

• Brand Name: DETECTO IN-BED SCALE
• Type of Device: DETECTO IN-BED SCALE
• Manufacturer (Section D): DETECTO; webb city MO 64870
• MDR Report Key: 5748018
• MDR Text Key: 48208508
• Report Number: MW5063002
• Device Sequence Number: 1
• Product Code: MNW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IB600
• Device Catalogue Number: 15306029
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 138