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

Model Number 7500

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2015

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating the head section would not lower when cpr lever was used.The bed was located on the step down unit 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

Hill-rom technical support paged a field technician at the request of the account.It is necessary for the progressa bed to have an effective maintenance program.We recommend that you do annual preventive maintenance.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 did not show hill-rom performed any preventative maintenance on this bed.It is unk if the facility performs preventative maintenance on their beds.No further info is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant info is identified following completion of the investigation, the additional relevant info will be submitted in a supplemental report.

• Brand Name: PROGRESSA 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: 4731083
• MDR Text Key: 5702920
• Report Number: 1824206-2015-00526
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2015

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: 7500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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