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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERMOBIL AB (PAB) PERMOBIL F5 CORPUS; POWERED WHEELCHAIR

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PERMOBIL AB (PAB) PERMOBIL F5 CORPUS; POWERED WHEELCHAIR Back to Search Results
Model Number F5 CORPUS
Device Problems Unintended Collision (1429); Unintended Movement (3026)
Patient Problems Bone Fracture(s) (1870); Limb Fracture (4518)
Event Date 11/12/2021
Event Type  Injury  
Event Description
Permobil ab received report claiming while the end-user was driving their device out-of-doors, the device reportedly struck a curbside which caused the device to stop abruptly.The sudden stoppage reportedly caused the end-user to lose positioning and fall out of the seating to the ground where it was reported they sustained serious injury requiring medical intervention.
 
Manufacturer Narrative
Information provided to permobil ab from the service provider claim as the end-user was operating their power wheelchair out-of-doors on a local street, the device reportedly maneuvered into a curb side.It was reported upon impact, the device abruptly stopped, forcing the end-user to lose positioning and fall to the ground where they were reported to have sustained a broken ankle.The end-user could not provide any information as to what may have led to impacting the curb, nor was any claim or allegation made that the permobil device malfunctioned or deviated in operation to have contributed to the event.Permobil technicians inspected the device and found it to remain fully operational with no signs of electrical or mechanical issues that may have contributed to this event.As device was fully operational with no signs of a previous malfunction having occurred, it is permobil ab's contention that the most likely cause of the event was user error in maneuvering the power wheelchair into a curb side that is higher than what the device was designed to accommodate.The dhr was reviewed, and the device was found to have met specification prior to distribution.
 
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Brand Name
PERMOBIL F5 CORPUS
Type of Device
POWERED WHEELCHAIR
Manufacturer (Section D)
PERMOBIL AB (PAB)
per uddens vag 13
timra, 86123
SW  86123
Manufacturer (Section G)
PERMOBIL AB (PAB)
per uddens vag 20
timra, 86123
SW   86123
Manufacturer Contact
kevin bullock
300 duke drive
lebanon, TN 37090
8007360925
MDR Report Key13232473
MDR Text Key287345220
Report Number1221084-2022-00001
Device Sequence Number1
Product Code ITI
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K143014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/12/2022
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
Device Operator Lay User/Patient
Device Model NumberF5 CORPUS
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/14/2021
Initial Date FDA Received01/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient SexPrefer Not To Disclose
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