MAUDE Adverse Event Report: HILL-ROM BATESVILLE PROGRESSA FRAME; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number P7500A000181

Device Problem Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technical support representative performed troubleshooting over the phone with the account, asking the account to inspect the patient right side brake activation limit switches for proper operation.It is necessary for the progressa" bed to have an effective maintenance program.We recommend that you do annual preventive maintenance.Examine the brakes to see whether the bed moves when the brakes are set.Replace as necessary.Examine the steering mechanism.Replace or adjust the steering control elements of the steering caster if necessary.Replace the caster if necessary.Troubleshoot in the event of a malfunction.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.Hill-rom technical support contacted the customer two additional times trying to obtain the resolution for this alleged issue.No response has been received from the account.Based on this information, no further action is required.

Event Description

Hill-rom technical support received a report from the account stating the brake not set alarm was working intermittently (cutting in and out).The bed was located in the bed shop at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: PROGRESSA FRAME
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 6089760
• MDR Text Key: 59887076
• Report Number: 1824206-2016-00480
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: P7500A000181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2014
• 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