MAUDE Adverse Event Report: SIZEWISE SIZEWISE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Patient Problem Fall (1848)

Event Date 12/21/2023

Event Type  malfunction  

Event Description

Situation: witnessed patient fall due to bed alarm malfunctioning on specialty bed.Bed alarm was on but never alarmed.Background: patient is a stroke patient, ambulating with therapy at times.Assessment: patient confused, attempting to walk to bathroom to urinate.Rounding by nurse was 10 minutes prior and toileting offered.Recommendation: patient moved back to a regular bed as the alarm malfunctioned on the rental.Bed alarm on.This was a rental bed that was returned to the company after this patient fell.Company was notified of malfunctioning bed alarm.Manufacturer response for specialty bed, (brand not provided) (per site reporter) manufacturer was notified and retrieved the bed.

• Brand Name: SIZEWISE
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): SIZEWISE; 500 commerce pkwy; hays KS 67601
• MDR Report Key: 18621427
• MDR Text Key: 334309064
• Report Number: 18621427
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/04/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other