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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 Problems Bent (1059); Unintended Movement (3026)
Patient Problem Pain (1994)
Event Date 09/14/2015
Event Type  Injury  
Event Description
It was reported while moving a patient across a doorway saddle, the stair chair allegedly gave way and the emt lost their footing allowing the chair and patient to fall backwards.The patient allegedly hit her head on the o2 bag and later complained of some head pain.The customer reported the only noticable damage to the chair was a bent release bar; however, the chair is being returned to ferno for evaluation.
 
Manufacturer Narrative
The device was visually and functionally evaluated.The condition of the unit indicates it has had extensive use for its age.The locking mechanism was functional and no malfunctions were detected throughout the evaluation.It could not be determined how the lock bar was bent; however, it was confirmed the bend to the lock bar does not impair the function of the lock bar.The customer was asked if they had received any feedback from the hospital or the patient regarding serious injury related to the incident and they stated they had received no such communication.
 
Event Description
It was reported while moving a patient across a doorway saddle, the stair chair allegedly gave way and the emt lost their footing allowing the chair and patient to fall backwards.The patient allegedly hit her head on the o2 bag and later complained of some head pain.The customer reported the only noticable damage to the chair was a bent release bar; however, the chair is being returned to ferno for evaluation.
 
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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 Key5106118
MDR Text Key26827631
Report Number1523574-2015-00083
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 health professional
Reporter Occupation Emergency Medical Technician
Type of Report Followup
Report Date 11/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Emergency Medical Technician
Device Model Number0714851
Device Catalogue NumberPT4010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/16/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2015
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
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