MAUDE Adverse Event Report: XIAMEN WORLD GEAR SPORTS GOODS CO., LTD DRIVE DEVILBISS HEALTHCARE; BARIATRIC BED,

Model Number	P503
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We checked and reviewed the device history record for bed p503 (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 many 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.We checked the inspection report for this bed and found that the bed included all the qualified components/accessories needed before it left factory.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 end cap may be taken out when the user added width extension then it was forgotten to be placed back or it was missed during use and wasn't replaced with another one in time.
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bed by the provider who stated the bed was missing a cover on the endcap of the metal bed frame.The end user received a cut to their shin that required stitches when they fell under the bed and caught their leg on the edge.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
• Common Device Name: BARIATRIC BED,
• 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: 19835077
• Report Number: 3004168774-2024-00003
• Device Sequence Number: 6627679
• Product Code: OSI
• UDI-Device Identifier: 00822383982823
• UDI-Public: 00822383982823
• Combination Product (Y/N): N
• 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): 07/23/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: P503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2021
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male