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

Model Number 0012801

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2014

Event Type  malfunction  

Event Description

While off loading the empty cot from the ambulance, for a pt pickup, the cot did not fold up/down properly.The cot was manipulated so it would fold up and no injury was sustained by pt or emt.The customer stated that a similar incident occurred one month prior while loading a pt into the ambulance.The cot was, again, manipulated so that it would fold and no injuries were sustained.

Manufacturer Narrative

We are reporting this incident due to a potential delay in transport as opposed to any likelihood of injury.The product is 24 yrs old and end user has no maintenance program with an authorized service agent.

• Brand Name: 28Z COT CHAIR
• Type of Device: 28Z COT CHAIR
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; wilmington OH 45177
• Manufacturer Contact: dawn greene ; 70 weil way; wilmington, OH 45177 ; 9372832900
• MDR Report Key: 3776165
• MDR Text Key: 4373784
• Report Number: 1523574-2014-00004
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0012801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/1990
• 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 Age: 47 YR
• Patient Weight: 64