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

Model Number P1900H006539

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 05/18/2022

Event Type  Injury  

Event Description

The customer reported that the exit alert of the total care bed did not alarm when the patient exited the bed and the patient fell.Follow up with the customer found that the patient was admitted for altered mental status and sustained significant facial fractures from the fall.The patient was transferred to a facility with a higher level of care.The bed was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The customer reported that the exit alert of the total care bed did not alarm when the patient exited the bed and the patient fell.Follow up with the customer found that the patient was admitted for altered mental status and sustained significant facial fractures from the fall.The patient was transferred to a facility with a higher level of care.The totalcare bed is intended to provide patient support in health care environments.It is intended to be used to treat or prevent pulmonary or other complications associated with immobility, to treat or prevent pressure injury, or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The bed is equipped with a graphical caregiver interface touchscreen that allows the caregiver to view information for the bed's functions, set the bed¿s exit alarms, zero the bed¿s scale, weigh the patient and manipulate other features of the bed.Inspection of the bed by a hillrom technician found the bed and its components to be functioning as designed, noting that the patient's weight was found on the bed's scale.The technician zeroed the scale and tested for accuracy with weights.Fractures involving the bones face can range from minor to serious.Treatment is dependent on the complexity of the fracture.A minor fracture may be treated with out surgery using a closed-reduction technique.More complex fractures require medical/surgical intervention to reset and or repair the fractured bones.Although the device was found to be working as designed, based on the details provided that the patient was transfer to a higher care facility indicates that the reported event resulted in a serious injury.Therefore this event is considered reportable based on the injury involved.Based on this information, no further action is required.

• Brand Name: TOTALCARE 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: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 14604152
• MDR Text Key: 293371288
• Report Number: 1824206-2022-00268
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2022

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 Model Number: P1900H006539
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2005
• 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