MAUDE Adverse Event Report: HILL-ROM, INC. SPECIALTY BED ARISE LOW AIR LOSS (LAL) FROM JOERNS; BED, FLOATATION THERAPY, POWERED

Device Problem Positioning Problem (3009)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 11/30/2019

Event Type  Death  

Event Description

Pt fell from bed and found on the floor.Pt died shortly thereafter.Based on preliminary autopsy report, pt may have had a cardiac event.Specialty bed arise low air loss (lal) from joerns mattress rises above the side rails when the head of the bed is elevated.It also does not have any clinical alarms to alert when a pt may be exiting the bed.Fda safety report ids# (b)(4).

• Brand Name: SPECIALTY BED ARISE LOW AIR LOSS (LAL) FROM JOERNS
• Type of Device: BED, FLOATATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM, INC.
• MDR Report Key: 9503872
• MDR Text Key: 172420818
• Report Number: MW5091780
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Weight: 71