MAUDE Adverse Event Report: HILL ROM INC CLINITRON RITEHITE BED; BED, AIR FLUIDIZED

Model Number 0800

Device Problems Leak/Splash (1354); Device Slipped (1584)

Patient Problems Fall (1848); Injury (2348)

Event Date 12/18/2013

Event Type  Other  

Event Description

Hill rom received an email from the accounts claim representative stating they received workers compensation claims for a registered nurse who slipped and fell in sand leaking from a clinitron bed.Hill-rom representative called the accounts claim representative asking if there was any additional information for this complaint and they stated the registered nurse who slipped had sustained injuries and is out of work.

Manufacturer Narrative

Hill-rom representative spoke with the registered nurse that made the injury allegation.She stated that she slipped on the beads when she was returning to the patient and it was dark in the room due to the time of day and she did not see the beads.She slipped and then removed the patient from the leaking bed.The nurse stated that she did not get an mri on her lower back and has not received the results at this time.The nurse also stated that she has some preexisting injuries but would not give any further information.Per the hill-rom user manual warning, the beads are slippery on hard surfaces.If beads leak onto the floor, immediately clean them up with a damp cloth and notify your hill rom representative.Failure to do so could cause injury.The account has not provided a serial number for the bed involved in this incident.No record of a call for repair for this incident is known at this time.A supplemental report will be provided if this information becomes available.

• Brand Name: CLINITRON RITEHITE BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL ROM INC; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state route 46 e; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3601627
• MDR Text Key: 4091288
• Report Number: 1824206-2014-00194
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other