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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 93H PROFLEXX H FRAME COT
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FERNO-WASHINGTON, INC. 93H PROFLEXX H FRAME COT Back to Search Results
Model Number 0015758
Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)
Patient Problems Contusion (1787); Swelling (2091); No Consequences Or Impact To Patient (2199); Physical Entrapment (2327)
Event Date 08/18/2015
Event Type  Injury  
Event Description
It was reported that when the cot was in the intermediate position and a patient was in the process of getting off the cot, the cot allegedly dropped to the lowest position and struck the foot of the attending emt.The customer stated the emt had her foot on the leg of the cot to stabilize it for the patient and when it lowered it caught her foot between the upper and lower leg portions.The emt alleged a contusion to her foot.The customer was contacted and they confirmed the emt did seek medical intervention at the hospital and was release with only minor swelling and was able to return to work with no missed time.The customer also reported there was no injuries to the patient.The device evaluation is pending and results will be reported in a supplemental report.
 
Manufacturer Narrative
The stretcher was evaluated on 8/26/2015.The stretcher was found to be jammed in a position below the lowest position.It was found the plunger pin had been jammed.Once the pin was unjammed and the pin housing was returned to a normal position, the cot operated as intended.The stretcher was tested with 200lbs and functioned according to specification.The incident could not be duplicated.There was no observation of any damage to the cot or the surrounding components.It could not be determined what caused the pin to become jammed.The emt was initially seen at the hospital for the alleged injury; however, she was able to return to work without missed time.No follow up information has been provided about long term injury.Ferno did provide use training to the crew members to assure proper operation of the stretcher.
 
Event Description
It was reported that when the cot was in the intermediate position and a patient was in the process of getting off the cot, the cot allegedly dropped to the lowest position and struck the foot of the attending emt.The customer stated the emt had her foot on the leg of the cot to stabilize it for the patient and when it lowered it caught her foot between the upper and lower leg portions.The emt alleged a contusion to her foot.The customer was contacted and they confirmed the emt did seek medical intervention at the hospital and was release with only minor swelling and was able to return to work with no missed time.The customer also reported there was no injuries to the patient.The device evaluation is pending and results will be reported in a supplemental report.
 
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Brand Name
93H PROFLEXX H FRAME COT
Type of Device
93H PROFLEXX H FRAME COT
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 Key5029790
MDR Text Key24046452
Report Number1523574-2015-00079
Device Sequence Number1
Product Code FPO
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 01/04/2016
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 Number0015758
Device Catalogue NumberPT9343
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/25/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2012
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;
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