MAUDE Adverse Event Report: HILL-ROM BATESVILLE CENTRELLA MED-SURG; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P7900B200233

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 02/24/2022

Event Type  Injury  

Manufacturer Narrative

It was initially reported by the hillrom account executive that a patient exited the centrella bed near one of the foot side rails and fell.A total of three patient falls were reported.No additional information was provided.This evaluation addresses patient #3.Additional information was obtained from the facility¿s director of nursing (don).The resident population at the facility where the falls occurred includes patients with advanced multiple sclerosis (ms), quadriplegic and paraplegic patients with cognitive impairment.The facility recently received new centrella beds within the last 2-4 weeks and the side rails seem shorter than before.The don stated the beds did not fail in any way; she believes the issue is with the design of the head side rail and that it is too short and provides less of a barrier.Additionally, the facility only uses two side rails (due to patient restraint laws) and has since received consent to use four side rails.The bed exit alarm is not utilized at the facility; by the time staff hears the alarm, the patient is already out of the bed.The patient involved in this complaint is a male patient with advance ms who fell out of bed and sustained a leg fracture.Per the don, there were "other issues at play" when the patient fell that she did not elaborate on.The patient was transported to the hospital and a cast was applied to immobilize the leg fracture.The patient was transferred back to the facility he resides at, and no additional medical intervention was required.Additionally, the don inquired about a bariatric bed for this patient as the centrella bed may not be the best option.The centrella smart+ bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.It is intended for a broad patient population as determined appropriate by the caregiver or institution.It is intended for patient populations weighing at least 70 lb (32 kg) and is capable of supporting patients up to 500 lb (227 kg).The centrella smart+ bed is intended to assist clinical staff by relaying bed data to hospital communication systems for display and monitoring.As no serial number was provided for this bed, a search of the hillrom maintenance records for any hillrom performed preventative maintenance on this bed was unable to be completed.It is unknown if the facility performs preventative maintenance on their beds.When the hillrom service technician arrived at the customer¿s facility, the patient was observed to be in the bed with side rails up and no alarm was set.The bed does not have the nurse call option.The service technician set the bed exit alarm and informed the customer.The bed was verified to be functioning as designed per functional, visual, and audible testing.However, the service technician noted the mattress on the bed was not a centrella mattress since it was not locked into the deck.Instructions for use warn to only use mattresses of the specified dimension and to contact customer service.Additionally, hill-rom recommends the use of hillrom mattresses that have been designed and tested specifically for the centrella smart+ bed.If you purchase a replacement mattress from hill-rom or another manufacturer, make sure that the safety features of the bed have been tested and verified to operate correctly with the replacement mattress.The replacement mattress should meet the applicable regulations and technical standards to minimize the risk of injury to the patients and caregivers.Additionally, mattresses should allow enough height from the top of the mattress to the top of the siderail to prevent accidental roll-overs.Although there was no malfunction of the device, the patient sustained a leg fracture because of the fall, which required medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.As the facility was not utilizing all of the bed's side rails or bed exit alarm (for reasons stated above) and not using a centrella mattress at the time of the patient fall, the injury can be attributed to misuse of the device.Hillrom considers this complaint reportable.Based on this information, no further action is required.

Event Description

Hillrom received a report by the hillrom account executive that a patient exited the centrella bed near one of the foot side rails and fell.This report was filed in our complaint handling system as complaint (b)(4).

• Brand Name: CENTRELLA MED-SURG
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 13684799
• MDR Text Key: 286846142
• Report Number: 1824206-2022-00132
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761985162
• UDI-Public: 010088776198516211211208
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2022

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 Model Number: P7900B200233
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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