MAUDE Adverse Event Report: SIZEWISE MANUFACTURING / RAYE'S, INC DBA SIZEWISE MANUFACTURING SIZEWISE EVOLUTION BED WITH SCALE SYSTEM; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Self-Activation or Keying (1557)

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

Event Date 01/13/2022

Event Description

"bed lowered itself straight to ground and loud bang was heard by bystanders.No hospital staff found cause of bang.Both charge nurse, nurse and physician stated no injury happened to patient during this accident.No staff was witnesses to this accident." fda safety report id# (b)(4).

• Brand Name: SIZEWISE EVOLUTION BED WITH SCALE SYSTEM
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): SIZEWISE MANUFACTURING / RAYE'S, INC DBA SIZEWISE MANUFACTURING; hays KS 67601
• MDR Report Key: 13542838
• MDR Text Key: 285766501
• Report Number: MW5107481
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1