MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. POWERFLEXX, RESCUE RED

Model Number 0015651

Device Problem Use of Device Problem (1670)

Patient Problems Hematoma (1884); Unspecified Tissue Injury (4559)

Event Date 02/08/2021

Event Type  Injury  

Event Description

It was reported, per fda report # mw5101531 received 6/15/21, an incident occuring on (b)(6) 2021 in which the medic crew had loaded the stretcher and patient into the ambulance when one of the medic's noticed the patient's legs were not restrained.They applied the leg restraint to the patient, but failed to notice the restraint was caught under the stretcher leg.When the operator's lowered the stretcher, it allowed the restraint to create excessive pressure on the patient's legs which resulted in the patient sustaining soft tissue damage and a hematoma.The customer reported the cot was evaluated and returned to service however; no details of the evaluation were provided.The customer reported finding the operators incorrectly restrained the patient legs and advised this was a use error.Proper instructions for how to restrain a patient, can be found in the ifu.The serial # was requested, but not provided.

• Brand Name: POWERFLEXX, RESCUE RED
• Type of Device: POWERFLEXX, RESCUE RED
• 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 Key: 12052680
• MDR Text Key: 258010105
• Report Number: 1523574-2021-00007
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 0015651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 104