MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. IN X, FOR INLINE

Model Number	0015803
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant reported after loading a patient onto the stretcher and raising the stretcher to the transport height, the medic team observed the cot seemed off balance.It was then noted the crossbar had allegedly broken.The patient was transferred to a hospital bed and a backup stretcher was utilized.No injuries were reported.
Additional Manufacturer Narrative
The customer provided pictures of the stretcher for review and the reported issue was able to be confirmed.The customer is cot care trained and conducted the evaluation and repair of the stretcher onsite.It was reported the stretcher has been returned to service.No injuries have been reported since the initial reporting.
Event or Problem Description
Complainant reported after loading a patient onto the stretcher and raising the stretcher to the transport height, the medic team observed the cot seemed off balance.It was then noted the crossbar had allegedly broken.The patient was transferred to a hospital bed and a backup stretcher was utilized.No injuries were reported.

• Brand Name: IN X, FOR INLINE
• Common Device Name: IN X, FOR INLINE
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington, oh OH 45177
• MDR Report Key: 9628848
• Report Number: 1523574-2020-00003
• Device Sequence Number: 11459947
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/26/2020

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: 0015803
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 91