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

Model Number 1600

Device Problem Insufficient Information (3190)

Patient Problem Physical Entrapment (2327)

Event Date 05/15/2014

Event Type  malfunction  

Event Description

The account reported that they have a female patient on an advanta bed with a zoneaire mattress on it without hbsw side rails and she has gotten her leg stuck between the mattress and the bottom of the side rail.The bed was located in the nursing home.There was no patient/user injury.The patient required some assistance to get her leg out.(b)(4).

Manufacturer Narrative

The account acknowledges that this bed was manufactured before the current side rail entrapment guidelines were established.The bed as grandfathered in for use at the account.Hill-rom technical support spoke with the executive director at the account and she stated that the patient was not trapped in or under the side rail.The patient had slipped down the bed and had her foot between the foot side rail and the foot board almost to the floor.The account is going to install the hbsw kit on this bed.The patient that was in this bed has been transferred to a different bed and the account stated that this bed will only be used by patient's that do not need the side rail up until the hbsw kit is installed.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.The account ordered the hbsw sruk, advanta kit and the issue will be resolved upon installation by the account.Based on this information, 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: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3974975
• MDR Text Key: 4822131
• Report Number: 1824206-2014-01758
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2014

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: 1600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2014
• Initial Date FDA Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2003
• 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