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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. MONDIAL ST64 AMBULANCE STRETCHER
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FERNO-WASHINGTON, INC. MONDIAL ST64 AMBULANCE STRETCHER Back to Search Results
Model Number 0054240
Device Problems Device Tipped Over (2589); Device Fell (4014)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 12/10/2018
Event Type  Injury  
Event Description
It was reported while rolling a patient on the cot into the hospital the front wheels hit a low threshold and the front legs allegedly collapsed to the ground.It was further alleged the patient's head made contact with the ground and medical attention was provided; however, no details on the nature of the alleged injury or medical attention was provided.
 
Manufacturer Narrative
Additional information was provided by the complainant advising the incorrect serial number of the stretcher was provided.The correct serail number (12s007326 - dom 2/02/12) has been updated on this report.The complainant conducted a visual and functional evaluation of the stretcher and advised the contributing factor of the incident was a lack of proper service/maintenance of the loading wheel system.The stretcher was repaired and returned to service.It was also later reported the patients injury was minor and non-life threatening.This adverse event report was submitted in error as this product is designed for international use and is not distributed in the us.
 
Event Description
It was reported while rolling a patient on the cot into the hospital the front wheels hit a low threshold and the front legs allegedly collapsed to the ground.It was further alleged the patient's head made contact with the ground and medical attention was provided; however, no details on the nature of the alleged injury or medical attention was provided.
 
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Brand Name
MONDIAL ST64 AMBULANCE STRETCHER
Type of Device
MONDIAL ST64 AMBULANCE STRETCHER
Manufacturer (Section D)
FERNO-WASHINGTON, INC.
70 weil way
wilmington OH 45177
MDR Report Key8264072
MDR Text Key133709325
Report Number1523574-2019-00002
Device Sequence Number1
Product Code FPO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number0054240
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age72 YR
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