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

Device Problem No Audible Alarm (1019)

Patient Problems Death (1802); Hemorrhage, Subdural (1894); Neurological Deficit/Dysfunction (1982)

Event Date 03/21/2019

Event Type  Death  

Event Description

Nurse noted the bed alarm was on the beginning of the shift, as evidenced by the green light indicated the alarm was on.Patient was a high fall risk.At approximately 0430, the patient got out of bed, and the alarm did not sound.She fell and hit her head and a small subdural was noted.She had further neurological changes and the bleed had expanded.She died later that afternoon.

• Brand Name: SIZEWISE BEHAVIORAL HEALTH BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): SIZEWISE; lenexa KS 66215
• MDR Report Key: 8469566
• MDR Text Key: 140509536
• Report Number: MW5085377
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• 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: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• 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): Death
• Patient Age: 83 YR
• Patient Weight: 66