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

Model Number	P903
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Head Injury (1879)
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.
Additional Manufacturer Narrative
We checked and reviewed the device history record for bed p903 (sn: (b)(6).It was manufactured in accordance with the device's dmr and it has passed all tests according to the requirements of iec60601-2-52.This bed was manufactured by world gear (manufacturer) and put into the market for use by world gear's customer (importer) for over 7 years.As the brand (drive devilbiss healthcare) belongs to the importer, it is importer's responsibility to inform or train the caregivers how to operate the device and the general attention and risk about the use of this device.As the end user won't return the bed for evaluation, per our analysis and evaluation based on the records and test reports, we believe that the event was caused by misuse.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): XIAMEN WORLD GEAR SPORTS GOODS CO., LTD; no. 27-29 north 2nd road,; xinglin, jimei district; xiamen, fujian 36102 2; CH 361022
• Manufacturer (Section G): XIAMEN WORLD GEAR SPORTS GOODS CO., LTD; no. 27-29 north 2nd road,; xinglin, jimei district; xiamen, fujian 36102 2; CH 361022
• Manufacturer Contact: lisa huang ; no. 27-29 north 2nd road,; xinglin, jimei district; xiamen, fujian 36102-2 ; CH 361022
• MDR Report Key: 18842990
• Report Number: 3004168774-2024-00001
• Device Sequence Number: 20916037
• 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: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2024
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female