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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENYANG HENYI ENTERPRISE CO. DRIVE; BED
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SHENYANG HENYI ENTERPRISE CO. DRIVE; BED Back to Search Results
Model Number 15030BV-HR
Device Problems Overheating of Device (1437); Material Deformation (2976)
Patient Problems Burn(s) (1757); Tissue Breakdown (2681)
Event Type  Injury  
Event Description
Drive devilbiss healthcare was notified of an incident involving an electric bed, which is intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program.The end user of the bed stated that "he was injured and developed breakdown and has an open wound on his back" the end user did not seek medical attention.Drive did not receive any information regarding the patient's overall pressure injury management program.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.
 
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Brand Name
DRIVE
Type of Device
BED
Manufacturer (Section D)
SHENYANG HENYI ENTERPRISE CO.
no.386-3 qingnian st.
heping dis., shenyang liaoning 11000 4
CH  110004
MDR Report Key16388739
MDR Text Key309684823
Report Number2438477-2022-00137
Device Sequence Number1
Product Code FNL
UDI-Device Identifier00822383211534
UDI-Public00822383211534
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number15030BV-HR
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/07/2023
Distributor Facility Aware Date10/26/2022
Device Age2 YR
Date Report to Manufacturer02/14/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient SexMale
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