MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. PRO 28Z CHAIR COT

Model Number	0012826
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported while transporting a patient, the patient held onto the edge of the mattress, with her fingers tucked around it, when her fingers were allegedly pinched as the stretcher flexed.The patient allegedly sustained a laceration on the left middle and right ring finger, as a result.Intervention consisted of a bandage and first aid treatment in the er.No further details were provided.The stretcher will be evaluated.
Additional Manufacturer Narrative
The device was evaluated by an authorized service technician.No issues were found that would have contributed to the incident.The cot was evaluated, tested and returned to service.No further details were provided pertaining to the patient injury.
Event or Problem Description
The customer reported while transporting a patient, the patient held onto the edge of the mattress, with her fingers tucked around it, when her fingers were allegedly pinched as the stretcher flexed.The patient allegedly sustained a laceration on the left middle and right ring finger, as a result.Intervention consisted of a bandage and first aid treatment in the er.No further details were provided.The stretcher will be evaluated.

• Brand Name: PRO 28Z CHAIR COT
• Common Device Name: PRO 28Z CHAIR COT
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 12071409
• Report Number: 1523574-2021-00008
• Device Sequence Number: 4000349
• Product Code: FPO
• UDI-Device Identifier: 00190790002671
• UDI-Public: 00190790002671
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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 Expiration Date: 12/13/2019
• Device Model Number: 0012826
• Device Catalogue Number: 0012826
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 08/12/2021
• 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 Weight: 59