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

Model Number	P703
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We checked and reviewed the device history record for bed p703 (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.The product itself is safe and reliable based on the analysis and evaluation of records and test reports.This product has been manufactured and used for many years without any occurrence of such issues.Ultimately, we believe the incident is caused by improper use by the user.
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bed by the end user's daughter who stated that the end user fell between the bed rails and bumpers onto the floor.It was unclear how the bed and accessories were assembled.The end user had bruising to their shoulder and a cut across their tear duct on the left eye.She went to the emergency room and had x-rays and a ct scan, and was prescribed an antibiotic cream for the cut across the tear duct.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS HEALTHCARE PRIME CARE BED
• 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 ; CH
• Manufacturer Contact: lisa huang ; no. 27-29 north 2nd road; xinglin, jimei district; xiamen, fujian ; CH
• MDR Report Key: 23919163
• Report Number: 3004168774-2025-00001
• Device Sequence Number: 15741281
• Product Code: FNL
• UDI-Device Identifier: 00822383979434
• UDI-Public: (01)00822383979434
• Combination Product (Y/N): Y
• 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): 12/17/2025

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: P703
• Device Catalogue Number: P703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2025
• 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: Other
• Patient Sex: Female