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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM BATESVILLE ENVELLA BED; BED, AIR FLUIDIZED

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HILL-ROM BATESVILLE ENVELLA BED; BED, AIR FLUIDIZED Back to Search Results
Model Number P0819A
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2022
Event Type  malfunction  
Event Description
The customer reported the right-siderail on the envella bed came off and landed on a patient care technician¿s (pct) foot knuckles.The bed was moved to the service elevators and the hillrom service technician noted the side rail was missing from the bed and could not be located.Staff was still looking for the siderail and stated they would contact hillrom when found.This report was filed in our complaint handling system as complaint # (b)(4).
 
Manufacturer Narrative
The customer reported the right-siderail on the envella bed came off and landed on a patient care technician¿s (pct) foot knuckles.The incident was reported by a nurse to a hillrom service technician that was on site at the hospital.Per the nurse, the incident occurred on (b)(6) 2022 around 22:30 in room 450, bed 2.Per the nurse, the pct¿s foot was still hurting 20 minutes later when she went to a different floor.The pct and a witness to the incident were not available to speak with the hillrom service technician.The bed was moved to the service elevators and the hillrom service technician noted the side rail was missing from the bed and could not be located.Staff was still looking for the siderail and stated they would contact hillrom when found.Follow up was performed with the nurse manager of the unit where the incident occurred.The nurse manager was unaware of this incident and obtained further information from the assistant manager on night shift.The assistant manager on night shift stated there may have been a miscommunication about the bed involved.The nurse manager stated they are not sure if an envella bed was involved but rather one of their "low beds" (manufacturer not reported).The nurse manager stated if that is the case, no further follow up would be needed; however, the nurse manager is still trying to confirm with the pct what bed was involved.The nurse manager stated the pct was okay and went back to work.No medical intervention was reported.The nurse manager stated she would call back if they could confirm the correct bed.The envella air fluidized therapy system is intended for medical purposes to help treat or prevent pressure injuries, to treat severe or extensive burns, or to aid in circulation.This bed is an ideal support for patients who have advanced pressure injuries, flaps, grafts, or burns, and require frequent transfers or variable head elevation, and any other conditions appropriate for air fluidized therapy.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in (b)(6) 2021.It is unknown if the facility performed any other preventative maintenance on this bed.An inspection of the bed has not been completed as the customer has not contacted hillrom to state the siderail was located.Pain may be a symptom due to preexisting injury contained to a discrete area or a symptom felt more diffusely due to disorder or disease; however, pain is not an injury of itself.Pain is an unpleasant sensation that typically stops once the stimulus is removed.Pain is not life-threatening and does not require medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.There was no report of medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure associated with the reported event, which concludes no serious injury occurred (negligible injury).Although the customer stated there may have been a miscommunication regarding the bed involved in this incident, it was initially reported to the hillrom service technician as an envella bed and confirmation that a different bed was involved has not been received.At this time, an inspection cannot be performed to determine the cause of the siderail failure as the customer has not contacted hillrom to report if the siderail was located.It is likely the reported failure could cause or contribute to a serious injury or death if the failure were to recur.No further information is available on the repair of the bed at this time.If any additional relevant information is identified following completion of the repair, the additional relevant information will be submitted in a supplemental report.Based on this information, no further action is required.
 
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Brand Name
ENVELLA BED
Type of Device
BED, AIR FLUIDIZED
Manufacturer (Section D)
HILL-ROM BATESVILLE
1069 state route 46 east
batesville IN 47006
Manufacturer Contact
brad wheeler
1069 state route 46 east
batesville, IN 47006
3128199307
MDR Report Key15849691
MDR Text Key307877691
Report Number1824206-2022-00509
Device Sequence Number1
Product Code INX
UDI-Device Identifier00887761013834
UDI-Public010088776101383411180207
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/22/2022
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 Model NumberP0819A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/28/2022
Initial Date FDA Received11/22/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/07/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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