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

Model Number P0819A

Device Problem No Audible Alarm (1019)

Patient Problem Fall (1848)

Event Date 09/17/2021

Event Type  Injury  

Manufacturer Narrative

No issue found with the 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.The bed also can be used for intractable pain, extensive epidermal detachment, stevens-johnson syndrome, purpura fulminans, induce relaxation which may reduce need for sedative and pain medication, improve patient outcome, and reduce wound healing time.The bed permits easy positioning and egress, thereby enhancing the independence of patients.Additional information was obtained from the customer on 28sep2021.The reported event involved a (b)(6) year-old female that was admitted to the long-term care (ltc) facility for rehab post-cva and was recently moved from the rehab unit to long term care.On (b)(6) 2021, the patient was found lying on the floor near her bed.The patient was unable to express herself clearly but verbalized that she fell reaching for water.The patient had a superficial cut and soreness to her right arm and a hematoma on her head.The customer stated the facility does not use siderails as they are considered a restraint.There was no alarm from the bed and to the customer's knowledge, there was no other bed alarm system in place.No malfunction of the bed was reported.The patient was taken to the hospital by ems where a ct showed "multiple bleeding in brain".Further diagnostic imaging showed an unspecified injury of the superior mesenteric artery (unknown if new or medical history) and an unspecified fracture of lumbar vertebrae l3-l4.The patient has a medical history of diabetes mellitus and hyperlipidemia.The patient was monitored while hospitalized and no surgical intervention was reported.Final diagnosis per the patient's medical record was subdural hemorrhage with loss of consciousness of unspecified duration.On (b)(6) 2021, the patient was discharged from the hospital to the ltc facility.No additional information was provided.The bed was inspected by a hillrom service technician and it was noted the wrench light was on.Inspection of the bed found that the filters needed to be changed.The bed functioned as designed per functional, visual, and audible testing.The hillrom service technician also noted during inspection that the facility does not use siderails.The envella user manual states siderails are intended to be a reminder to the patient of the bed's edges, not a patient restraining device.The envella user manual states a siderail sensor error message will display when the user attempts to use a bed exit function and a siderail is not fully latched.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in january 2021.It is unknown if the facility performed any other preventative maintenance on this bed.It is unlikely the malfunction would cause or contribute to a serious injury or death if it were to recur.However, a subdural hemorrhage is a serious head injury and the patient required medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Additionally, the customer acknowledged that siderails were not in use at the time of the patient fall.Therefore, hillrom considers this a reportable misuse and serious injury.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating a patient was reaching for water when she fell out of the envella bed and was taken to the hospital with a brain bleed.It was also reported the wrench light was on.The customer stated the bed did not cause the fall.The bed was located at the account.There was patient injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: ENVELLA BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 12549847
• MDR Text Key: 274098690
• Report Number: 1824206-2021-00487
• Device Sequence Number: 1
• Product Code: INX
• UDI-Device Identifier: 00887761013834
• UDI-Public: 010088776101383411161111
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 09/29/2021

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?: No
• Device Operator: No Information
• Device Model Number: P0819A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR