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

Model Number 1600

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 07/10/2015

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician is evaluating this bed.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.

Event Description

Hill-rom received a hill-rom technician stating the bed exit alarm would alarm at the nurses' station but not at the bed.The bed was located in room 330 of the facility.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: ADVANTA 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: 4992355
• MDR Text Key: 23384578
• Report Number: 1824206-2015-00779
• 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
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2004
• 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