MAUDE Adverse Event Report: HILL-ROM, INC. VERSACARE BED; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number 3200

Device Problems Sticking (1597); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2015

Event Type  malfunction  

Event Description

Hill-rom received a report from a hill-rom technician stating the head section would not lower when cpr lever was used.The bed was located in the bed shop at the account.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The hill-rom technician found the cpr cable was disconnected from the handle.Per the hill-rom service manual, perform annual preventive maintenance procedures to make sure all versacare bed components are functioning as originally designed.Examine the handles, cables, and cpr mechanism on the head motor.Make sure the screws are installed and fully tightened.Examine the condition of the two cpr release handles, cpr cable, and cpr mechanism on the head motor.Operate the head section to the high position, then engage one of the cpr release.Make sure the head section lowers.Adjust the cpr cable as necessary.Do the same tests on the other side of the bed.Release the cpr handles and make sure the mechanism locks correctly when you operate the head up control for a few seconds.The head section must rise.Replace the head section motor in the event of a malfunction of the cpr cable if broken.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2015.It is unk if the facility performed any other preventative maintenance on this bed.The technician reconnected the cable to resolve the issue.Based on this info, no further action is required.

• Brand Name: VERSACARE BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4731080
• MDR Text Key: 5581177
• Report Number: 1824206-2015-00529
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2015

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: 3200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2015
• Initial Date FDA Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• 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