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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD9 DRIVE; TRANSPORT CHAIR
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HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD9 DRIVE; TRANSPORT CHAIR Back to Search Results
Model Number RTLFW19RW-RD
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Fall (1848)
Date of Event 03/04/2020
Type of Reportable Event Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a rollator.We have not received the device yet for evalustion.We are filing this report in an over abundance of caution.The end user was being pushed in the device from the hallway to the kitchen when the handles broke causing her to fall.  she hit her head but did not seek medical attention.
 
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Brand Name
DRIVE
Common Device Name
TRANSPORT CHAIR
Manufacturer (Section D)
HEBEI HEALTHPLUS MEDICAL DEVICE CO LTD9
1, chuangye st
sw industrial dist
matou eco industry pk, handan city 05604 6
CH  056046
MDR Report Key10028390
Report Number2438477-2020-00024
Device Sequence Number766098
Product Code INM
UDI-Device Identifier00822383246277
UDI-Public822383246277
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/29/2020
Report Date (Section F) 04/29/2020
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 Other
Device Model NumberRTLFW19RW-RD
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date03/04/2020
Device Age28 MO
Event Location Home
Date Report to Manufacturer04/30/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age73 YR
Patient Weight70
Date Report Sent to FDA04/29/2020
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