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

Model Number P3200E000035

Device Problem No Audible Alarm (1019)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

The customer reports that follow-up with staff confirmed the bed exit alarm was on, however the facility does not have the nurse call reports application to confirm settings of the alarm when the event occurred.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 device ifu states when the bed exit system is armed and it detects an alarm condition for the set bed exit mode (the patient moves from the center of the bed towards an egress point), an audible alarm comes on and indicators flash.The alarm sound and indicator flash continue until the user presses the optional alarm silence control or you deactivate the bed exit, even if the patient returns to the correct position on the bed.Inspection of the device by the customer biomed department and a hillrom technician noted the scale, nurse call, and bed exit to be functioning properly.A closed reduction is a medical procedure to line up the ends of a broken (fractured) bone without the need for surgery.This will help the fractured bone to heal correctly.Possible risks of a closed reduction can include blood clots and possible new fractures that could occur with the reduction.Although the bed and its components were found to be functioning as designed hillrom is reporting this event due to the injury necessitating medical intervention to preclude permanent impairment of the patient.Per the hillrom user manual, warning: the bed exit alarm system is not intended as a substitute for good nursing practices.The bed exit alarm system must be used in conjunction with a sound risk assessment and protocol.Per the hillrom user manual, if the bed exit alarm does not arm and all three mode indicators are flashing, remove the patient and zero the bed exit system.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in (b)(6) 2021.It is unknown if the facility performed any other preventative maintenance on this bed.The hillrom technician thoroughly inspected the bed and was unable to duplicate the reported issue.The bed functioned as designed.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the versacare bed exit did not alarm, and the patient fell.The patient sustained a fracture (customer unable to disclose location) with intervention of a closed reduction procedure to set the fracture without cutting the skin open.The bed was located at the account.There was no patient injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• 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: harish vishwanathan ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 12741951
• MDR Text Key: 279816852
• Report Number: 1824206-2021-00522
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2021

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: P3200E000035
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2007
• 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