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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 35-XST PROFLEXX

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FERNO-WASHINGTON, INC. 35-XST PROFLEXX Back to Search Results
Model Number 0015790
Device Problems Material Twisted/Bent (2981); Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/08/2019
Event Type  malfunction  
Event Description
Complainant alleges while loading a patient into the ambulance the drop frame allegedly bent when the foot end of the cot was lifted.The operators then chose to have the patient transferred to another stretcher to complete the transfer.No injuries or delay in treatment were reported as a result of the incident.
 
Event Description
Complainant alleges while loading a patient into the ambulance the drop frame allegedly bent when the foot end of the cot was lifted.The operators then chose to have the patient transferred to another stretcher to complete the transfer.No injuries or delay in treatment were reported as a result of the incident.
 
Manufacturer Narrative
The cot was evaluated by an authorized field technician at the complainants site.A visual and functional evaluation wasconducted.The technician found the stretcher to be in proper working order however; the technician found the customer had incorrectly insalled the straps of an accessory to the drop frame.This allowed the drop frame to bend when pressure was applied to the accessory.The ifu provides clear instruction for the proper installation of the accessory.
 
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Brand Name
35-XST PROFLEXX
Type of Device
35-XST PROFLEXX
Manufacturer (Section D)
FERNO-WASHINGTON, INC.
70 weil way
wilmington OH 45177
MDR Report Key8721964
MDR Text Key149206176
Report Number1523574-2019-00021
Device Sequence Number1
Product Code FPO
UDI-Device Identifier00190790000585
UDI-Public00190790000585
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 06/28/2019
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 Health Professional
Device Model Number0015790
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/12/2019
Initial Date FDA Received06/21/2019
Supplement Dates Manufacturer Received06/12/2019
Supplement Dates FDA Received06/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight64
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