MAUDE Adverse Event Report: HILL-ROM INC ADVANTA II; BED, AC-POWERED ADJUSTABLE

Device Problems No Audible Alarm (1019); Improper or Incorrect Procedure or Method (2017)

Patient Problem Fall (1848)

Event Date 01/15/2018

Event Type  malfunction  

Event Description

We had an incident last month in which the rn thought she had set the bed alarm on a patient who was a high fall risk.The patient got out of bed on her own.The bed did not alarm and she fell.Afterwards, the rn stated that she specifically remembered pushing the button to set the bed alarm, and hearing it beep, so she thought it was set.Come to find out, the bed alarm button beeps whether the alarm is set or not.She needed to look under the bed where a light changes to confirm that the alarm is set.In speaking with the unit nurse manager she told me a disadvantage with these beds is that there is an amber light on the side where the buttons are, and it is always on.Additionally, the beep when pushing the button to set the bed alarm does not confirm that it is set; the rn has to look under the bed to confirm it is set.I realize that this is a use error, but i wanted to report it because i feel that this 2-step process to confirm that the alarm is set is somewhat burdensome and easily missed.

• Brand Name: ADVANTA II
• Type of Device: BED, AC-POWERED ADJUSTABLE
• Manufacturer (Section D): HILL-ROM INC; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 7320135
• MDR Text Key: 101784357
• Report Number: 7320135
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2018
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO