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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 40-OS CHAIR
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FERNO-WASHINGTON, INC. 40-OS CHAIR Back to Search Results
Model Number 0714851
Device Problem Detachment Of Device Component (1104)
Patient Problem Injury (2348)
Event Date 03/22/2018
Event Type  Injury  
Event Description
It was reported while transporting a patient up a flight of stairs the medic crew allegedly heard a piece of metal fall from the chair and felt the chair become unstable.The transfer of the patient up the stairs and to the awaiting stretcher was able to be completed; however, in an effort to stabilize the chair a medic is alleging a shoulder injury.The patient was not injured.The provided incident report indicated the medic did seek medical intervention; however, details of the alleged injury and medical treatment were marked confidential.The complainant further reported upon their inspection of the chair they found the pin which holds the locking mechanism had allegedly broke.
 
Manufacturer Narrative
The chair was returned to manufacturer for evaluation.After completion of the initial visual evaluation it was confirmed that one of the two pins making up the locking mechanism was missing.It was also observed the remaining pin was severly bent.The missing pin was not returned with the chair; therefore, it could not be determined if the pin broke or if it simply fell out due to missing hardware.The observed damage to the remaining pin is indicative of the chair being allowed to repeatedly impact the stairs while in use.This type of use will result in the deformation and/or failure of the locking pins.The complainant is an authorized technician for ferno products; therefore, the chair was returned to them, as is, with the recommendation to install 2 new locking pins on the chair prior to returning to service.There has been no additional information provided regarding the medic's alleged injury.The ifu for the chair provides sufficient instruction on how to operate the chair during patient transports to avoid damage to the chair.The ifu also provides instruction and resources for inspection and maintenance of the chair.
 
Event Description
It was reported while transporting a patient up a flight of stairs the medic crew allegedly heard a piece of metal fall from the chair and felt the chair become unstable.The transfer of the patient up the stairs and to the awaiting stretcher was able to be completed; however, in an effort to stabilize the chair a medic is alleging a shoulder injury.The patient was not injured.The provided incident report indicated the medic did seek medical intervention; however, details of the alleged injury and medical treatment were marked confidential.The complainant further reported upon their inspection of the chair they found the pin which holds the locking mechanism had allegedly broke.
 
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Brand Name
40-OS CHAIR
Type of Device
40-OS CHAIR
Manufacturer (Section D)
FERNO-WASHINGTON, INC.
70 weil way
wilmington OH 45177
Manufacturer (Section G)
FERNO-WASHINGTON, INC.
70 weil way
wilmington OH 45177
Manufacturer Contact
dawn greene
70 weil way
wilmington, OH 45177
9372832900
MDR Report Key7398912
MDR Text Key104427561
Report Number1523574-2018-00016
Device Sequence Number1
Product Code FPP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/04/2018
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 Emergency Medical Technician
Device Model Number0714851
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/02/2018
Initial Date FDA Received04/05/2018
Supplement Dates Manufacturer Received04/02/2018
Supplement Dates FDA Received05/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age57 YR
Patient Weight95
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