MAUDE Adverse Event Report: BARIATRIC BED

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 06/08/2017

Event Type  malfunction  

Event Description

Pt using a bariatric bed with overhead assembly with trapeze bar.The "snapper pin with catch assembly" appears to have loosened, causing the trapeze bar to come loose, striking the pt on the forehead.

• Brand Name: BARIATRIC BED
• Type of Device: BARIATRIC BED
• MDR Report Key: 6639658
• MDR Text Key: 77646676
• Report Number: MW5070401
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 150