MAUDE Adverse Event Report: HILL-ROM BATESVILLE TOTALCARE CONNECT SPORT+ W/MCM; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P1900NRENT01

Device Problem Unintended Movement (3026)

Patient Problem Brain Injury (2219)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

The hillrom technician evaluated the bed and found the bed was working as designed no malfunction found with the bed.The customer reported the patient had a change in mental status on (b)(6), one day prior to the reported fall, which the facility initially contributed to the patient¿s medication as the patient was sleeping the entire day.The customer stated caregivers entered the patient¿s room after hearing a loud noise and found the patient between the wall and the bed.Cpr was performed and the patient was transferred to micu at 2:30 am on (b)(6) 2021 and then to a different facility later that day where the patient reportedly underwent surgery for a dislodged shunt.The patient was returned to the facility on (b)(6) and the customer reports the patient is doing fine.A vp shunt functions to relieve pressure on the brain by draining extra cerebrospinal fluid.Common symptoms of shunt malfunction are lethargy or sleepiness, confusion, seizures, irritability, etc.It is reported that the bed¿s brake alarm was on, yet the brakes were working.The bed is designed to alarm when its brakes are not applied/set.Upon inspection of the bed by a hillrom technician accompanied by the customer found the bed had been moved to another room, the bed¿s exit alarm was on, the brakes to be working, and no issues could be duplicated.The device ifu states reliance is placed on the caregivers and their professional judgment to assess the safety of the patient when accommodated in a medical system made of the totalcare system, a combination of accessories and other medical devices, as well as any potential hazard arising from his or her physical and/or psychological condition, and additionally recommends that medical personnel determine the proper methods necessary to make sure a patient remains safely in bed.It is likely the patients reported change in mental status, due to complications of the patient¿s shunt, contributed to the fall as stated by the customer.However, it cannot be determined if the shunt was dislodged prior to or resulted from the fall.Therefore, hillrom is reporting this patient¿s fall and subsequent surgical intervention based on not knowing if the reported dislodged shunt resulted from the fall.Based on this information, no further action is required.

Event Description

Hillrom received a report from the customer initially reported that the bed was broken, the patient fell off the bed, was trapped between the bed and the wall, and sustained a sore/bruise on the left side of the head and a head injury.The patient¿s past medical history includes spina bifida, stage 4 coccyx pressure injury, vp shunt, and venous insufficiency in his legs.The bed was located at the account.There was patient injury reported due to dislodged shunt this report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: TOTALCARE CONNECT SPORT+ W/MCM
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: harish vishwanathan ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 11519123
• MDR Text Key: 250383077
• Report Number: 1824206-2021-00118
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P1900NRENT01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2009
• 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