MAUDE Adverse Event Report: HILLROM DE MEXICO S DE RL DE CV PROCEDURAL STRETCHER; WHEELED STRETCHER

Model Number 8005

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2014

Event Type  malfunction  

Event Description

The account reported the left side rail latch was missing so the side rail could not latch.The stretcher is located in the bed shop at the facility.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

Hill-rom technician support spoke with the account and gave them the part numbers for the side rail latch and hardware that are needed.No info was given on how the parts became missing.Per the hill-rom service manual it is necessary for stretchers to have an effective maintenance program.We recommend that you do annual preventative maintenance.Make sure the side rails are not bent or twisted.Make sure the latch mechanisms operate correctly.You must hear an audible click when the side rail is raised to the up position.Check for loose or missing hardware.Tighten, repair or replace as necessary.The account will replace the left side rail latch, bushing, screw and nut to resolve the issue.Based on this info, no further action is required.

• Brand Name: PROCEDURAL STRETCHER
• Type of Device: WHEELED STRETCHER
• Manufacturer (Section D): HILLROM DE MEXICO S DE RL DE CV; apodaca ; MX
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3843755
• MDR Text Key: 4661749
• Report Number: 3006697241-2014-00140
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2014
• Initial Date FDA Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1