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

Model Number 1600

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2014

Event Type  malfunction  

Event Description

Hill-rom tech support rec'd a report from the account stating the patient positioning module volume is too low.The bed was located at the account in the bed shop.There was no patient/user injury reported.(b)(4).

Manufacturer Narrative

The hill-rom technical support representative found the patient positioning module volume too low.The account will replace the patient positioning module to resolve the issue.Based on this info, no further action is required.

• Brand Name: ADVANTA BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 3783371
• MDR Text Key: 4440557
• Report Number: 1824206-2014-00959
• 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: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2003
• 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