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

Model Number 0015803

Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/23/2019

Event Type  Injury  

Event Description

The complainant reported while unloading a patient from the ambulance, the head end medic released the safety latch prior to the head end legs being deployed and the head end of the stretcher lowered unexpectedly.There were no reports of injury to the patient; however, the head end operating medic alleges a hand fracture as a result of the incident.Medical intervention was sought however, details were not provided.

Manufacturer Narrative

The cot was evaluated by an authorized field technician at the complainants site.A visual and functional evaluation was conducted.The technician found the safety bail was damaged however; the cot was otherwise found to be in working order.It could not be determined if the damage existed prior to, or as a result of the incident.The ifu provides clear instruction for proper unloading of the cot.No further details were provided pertaining to the alleged medic injury or if any further intervention was sought.

Event Description

The complainant reported while unloading a patient from the ambulance, the head end medic released the safety latch prior to the head end legs being deployed and the head end of the stretcher lowered unexpectedly.There were no reports of injury to the patient; however, the head end operating medic alleges a hand fracture as a result of the incident.Medical intervention was sought however, details were not provided.

• Brand Name: INX, FOR INLINE
• Type of Device: INX, FOR INLINE
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 8843172
• MDR Text Key: 152755246
• Report Number: 1523574-2019-00027
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

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 Number: 0015803
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 07/24/2019
• Supplement Dates FDA Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR