MAUDE Adverse Event Report: XIAMEN WORLD GEAR SPORTS DRIVE DEVILBISS HEALTHCARE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	P903
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/01/2024
Type of Reportable Event	Death
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving an electric homecare bed by the end user's sister, who reported that the end user was trying a new bed and fell out of it.The end user's sister believes the space between the top and bottom bed rails is too far apart, and that the bed is too narrow, and that those issues caused the end user to fall out of the bed.There was no report of any defect or malfunction of the bed.The end user sustained a neck injury and bruises, and was taken to the hospital and released that evening.The sister also reported that the end user could not move her head and was slurring her words, which she did not do before.The end user passed away 2 days after the incident.The end user's sister will not return the device for evaluation.An update will be filed if additional information becomes available.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): XIAMEN WORLD GEAR SPORTS; 27-29 north 2nd road; xiamen, 36102 2; CH 361022
• MDR Report Key: 18717964
• Report Number: 2438477-2024-00006
• Device Sequence Number: 20892705
• Product Code: FNL
• UDI-Device Identifier: 00822383787350
• UDI-Public: 822383787350
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2024
• Report Date (Section F): 02/15/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: P903
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/16/2024
• Event Location: Home
• Date Report to Manufacturer: 02/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female
• Date Report Sent to FDA: 02/15/2024