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

Model Number	0015710
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The complainant reported while unloading a patient from the ambulance, the legs of the stretcher struck the rear bumper and did not lower completely.The stretcher then allegedly missed the safety hook and tipped to the right landing on its right side.The patient reported right arm and rib pain.Details of the injury and medical treatment were not provided.
Additional Manufacturer Narrative
A visual and functional evaluation was conducted on the subject cot and the reported issue was not able to be duplicated.No malfunctions were observed and the cot was operating according to specification.The ifu for the product provides suficient instructions on maintaining control of the cot while unloading a patient.The complainant has not provided any further details regarding thealleged patient injury or medical intervention sought.
Event or Problem Description
The complainant reported while unloading a patient from the ambulance, the legs of the stretcher struck the rear bumper and did not lower completely.The stretcher then allegedly missed the safety hook and tipped to the right landing on its right side.The patient reported right arm and rib pain.Details of the injury and medical treatment were not provided.

• Brand Name: 35 X PROFLEXX
• Common Device Name: 35 X PROFLEXX
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 8632600
• Report Number: 1523574-2019-00019
• Device Sequence Number: 1654966
• Product Code: FPO
• UDI-Device Identifier: 00190790000332
• UDI-Public: 00190790000332
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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
• Operator of Device: Health Professional
• Device Model Number: 0015710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR