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

Model Number P7900B300019

Device Problem Misassembly by Users (3133)

Patient Problem Aspiration Pneumonitis (4455)

Event Date 02/22/2024

Event Type  Death  

Manufacturer Narrative

It was reported that the mattress on a centrella bed allegedly disconnected from the bed and slid down approximately 12-14¿ and the patient reportedly aspirated and subsequently died.The patient was a 70-year-old male weighting 89 kg and measuring 5 feet 9 inches in height.The patient had a gj-tube and had been on the centrella bed for approximately 6 weeks prior to the incident with no issues.The head of bed was ordered to be elevated at 40 degrees as standard of care for aspiration prevention related to enteral feeds (slow rate) and other risk factors.Prior to the reported incident, the patient was mobile and independent and the patient¿s oxygen saturation ranged from 93-97% on room air.The patient¿s level of consciousness was at baseline and no acute concerns prior to the event were reported.Just before 06:00 on (b)(6) 2024, during hourly checks by nursing staff, the patient was found to be in distress.The patient¿s head was no longer elevated, and the patient was having difficulty breathing.Tube feedings were immediately stopped, the mattress was reconnected to the bed, and the patient was boosted back into appropriate position.Nursing, respiratory therapy, and the physician performed an assessment of the patient.The patient was immediately placed on supplemental oxygen via a non-rebreather mask, then switched to 50% ventimask.The patient continued to worsen and was put on airvo 50l/min 80%, then 80l/min 100% o2.The patient was intubated after exceeding the limits of airvo and transferred to the intensive care unit (icu).Placement of the gj-tube was verified following the event.On an unreported date, the patient died.According to the physician review, the mattress not being attached and slipping in its positioning, contributed to poor positioning of the patient, which contributed to the aspiration event.The patient passed away because of the aspiration.Cause of death was listed as, gallstone pancreatitis resulting in aspiration pneumonia and multi-system organ failure secondary to sepsis.Per the customer, environment services (evs) staff does not disconnect the mattress when cleaning, except when cleaning the bed after a patient has been discharged, which did not occur for this patient.The mattress does not normally disconnect with regular use.Additionally, evs current practice is to fully extend the bed when cleaning, and flexafoot is not brought back in.The bed remained fully extended for the duration this patient was in the bed.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.The device instructions for use (ifu) provides the following cleaning instructions: to raise the mattress to clean underneath, find the mattress retention knobs on the underside of the mattress, and slide the knobs to the center of bed.Examine the following for damage: top mattress cover; bottom mattress cover and white attachment knobs; zipper closure.The damaged items should be replaced.To prepare the bed for use connect the mattress retention knobs at the head and foot ends of the mattress.The device ifu provides the following warning when installing a replacement mattress: set the length of the bed to the length of the mattress.To do so, use the flexafoot controls to adjust the foot section until the footboard aligns with the foot-end edge of the mattress.The baxter service technician attended the customer¿s facility on 28feb2024, and the mattress was still in patient use.Upon inspection of the bed, it was noted that the bottom mattress ticking around the two- foot end mattress attachment knobs was ripped.All the knobs were secured tightly, and there was no damage to the plastic pieces they are attached to.Also, all the knobs were in the correct position inside the mattress.The mattress model was unable to be confirmed as the tags had been removed.Additionally, it was learned that nursing staff did not have the head angle <30° limit control set at the time of the incident.The <30° limit control allows the caregiver to prevent the head of the bed to be lowered below 30°.The baxter service technician confirmed this alarm was active and functioning as expected.In this event, the patient required medical intervention (intubation, higher level of care) and subsequently died.The patient¿s cause of death was listed as gallstone pancreatitis resulting in aspiration pneumonia and multi-system organ failure secondary to sepsis.The facility¿s physician review concluded the mattress not being attached and slipping in its positioning, contributed to poor positioning of the patient, which contributed to the aspiration event.The bed was inspected by baxter and preliminary results found the ticking around the two-foot end mattress attachment knobs was ripped; however, all the mattress attachment knobs were tightly secured without damage.Due to the ongoing investigation into this incident, baxter is unable to rule out the bed caused/contributed to the patient death.The complaint record will be reassessed upon receipt of additional information.On 13mar2024 update: the customer provided the following information.The customer clarified the clinical team noticed the patient in distress, turned the lights on and noted that the mattress was moved down in the bed.The clinical team moved the mattress up into place, then boosted the patient up on the mattress.No repairs had been completed on the centrella bed by the customer since purchase (per etq, shipment date was 21jul2022).The customer will be implementing equipment checks to their rounding policies.Inspection of the bed by baxter found the mattress ticking around the foot end attachment knobs was torn.The customer alleged the mattress became disconnected from the bed frame and had to be reconnected; however, the mattress was confirmed to be securely connected to the bed frame at the time of baxter's inspection.The cause of the event is likely related to use error (failure to connect mattress retention knobs after cleaning/bed length not set to length of mattress).Prevention of this type of event is outlined in the device ifu.

Event Description

It was reported that the mattress on a centrella bed allegedly disconnected from the bed and slid down approximately 12-14¿ and the patient reportedly aspirated and subsequently died.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: 18938998
• MDR Text Key: 338066826
• Report Number: 1824206-2024-00368
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761985162
• UDI-Public: 010088776198516211220726
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: P7900B300019
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• 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): Death
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 89 KG