MAUDE Adverse Event Report: HILL-ROM BATESVILLE VERSACARE FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P3200J000019

Device Problem No Audible Alarm (1019)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/22/2022

Event Type  Injury  

Event Description

It was reported that the bed exit was not setting on the versacare bed, and a patient fell out of bed.The bed was located at the account.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

It was reported that the bed exit was not setting on the versacare bed, and a patient fell out of bed.At the time of the initial report, no patient injury was reported.Follow-up with the facility¿s risk management team found the patient was injured from the fall.The patient in this event was an 87-year-old male.X-ray showed a cervical fracture.The patient must wear a cervical collar for six weeks; no surgical intervention was required.Per the customer, the bed exit alarm had been going off all day but was reportedly not heard when the patient exited the bed at the time of the fall on 13aug2022 at 10:30 am.Staff caring for the patient was sure the bed exit alarm was set and to the customer¿s knowledge, the volume on the alarm had not been adjusted.No further information was provided.The versacare bed system is intended to provide a patient support suited to be used in healthcare environments.The versacare bed may be used in such settings as acute care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (pacu), and sections of the emergency department (ed).The hillrom service technician inspected the bed and tested the three-bed exit alarm system modes.All bed exit modes functioned as designed.All four siderails locked properly in the upright position.No issues were found with the bed.The bed functioned as designed per functional, visual, and audible testing.Cervical spine fractures in the elderly can be the result of ground-level falls, such as falling off a chair.Cervical spine fractures are high risk injuries that require medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Although the device was found to function properly, the patient fell from the versacare bed and sustained a cervical spine fracture, which is considered a serious injury.Therefore, this event is considered reportable serious injury.Based on this information, no further action is required.

• Brand Name: VERSACARE FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: melrita gilliam ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 15329309
• MDR Text Key: 298999738
• Report Number: 1824206-2022-00386
• Device Sequence Number: 1
• Product Code: FNL
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: P3200J000019
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2010
• 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: 87 YR
• Patient Sex: Male