MAUDE Adverse Event Report: SIZEWISE RENTALS, L.L.C. SIZEWIZE BARIATRIC BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problems Material Discolored (1170); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2022

Event Type  malfunction  

Event Description

Rn caring for patient reported to clinical supervisor that bed was sparking and caused black discoloration to mounted column in patient room.The sparking appeared to be at motor under bed.Rn immediately unplugged bed.Another bed was in hallway and had been ordered earlier for patient because the bed was a larger size.The patient was transferred to new bed.No harm to patient.

• Brand Name: SIZEWIZE BARIATRIC BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): SIZEWISE RENTALS, L.L.C.; 500 commerce pkwy; hays KS 67601
• MDR Report Key: 15657357
• MDR Text Key: 302269389
• Report Number: 15657357
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Male