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

Model Number P3200K000203

Device Problem Defective Alarm (1014)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

The hillrom technician found no malfunction with the bed.The customer reported no medical intervention was provided due to the patient being on hospice.Additionally, the customer report that the patient¿s cause of death was contributed to the patient¿s disease process and not the fall or the bed.The versacre¿s bed exit alarm system provides an audible and visual alert notification to the caregiver team.However, it is not intended as a substitute for good nursing practices.The device ifu states that the bed exit alarm system must be used in conjunction with a sound risk assessment and protocol.The inspection of the bed by a hillrom technician found the bed and all its components to be working as designed.Additionally, it is noted that the customer verified that the bed exit was working and contributes the event to possible use error.Although the patient's death was not contributed to the fall and medical intervention was not provided for this reported femoral neck fracture due to the patient's disease process typically a femoral fracture would require surgical intervention which meets the definition of a serious injury and is therefore reportable.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 did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician found no malfunction with the bed, the bed had an user error.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the versacare bed¿s exit alarm was not working and there was a patient injury.Follow up with the customer found that the patient was found on the floor, alarms had been documented as on but not sounding, the patient sustained a femoral neck fracture and subsequently expired.The customer reported no medical intervention was provided due to the patient being on hospice the bed was located at the account.There was no patient/user 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: 12332533
• MDR Text Key: 266929742
• Report Number: 1824206-2021-00415
• 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: 07/20/2021

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: P3200K000203
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2016
• 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