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

Model Number P3200K000019

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

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

The account initiated conservative measures for the clavicle fracture and then transferred the patient to a tertiary care facility for potential surgical repair of the hip.The account does not know what was done to care for the patient after she was transferred to the tertiary care facility.A hip fracture is a break in the upper quarter of the femur (thigh) bone.The extent of the break depends on the forces that are involved.Treatment for hip fractures usually involves a combination of surgery, rehabilitation and medication.The type of surgery used is primarily based on the bones and soft tissues affected or on the level of the fracture.Although details regarding the patient and treatment for the hip fracture was not provided, surgery is almost always required and therefore meets the definition of a serious injury.The account stated the bed exit alarm was set and did not sound at the bed.The account does not know if the bed exit alarm sounded at the nurses' station and it is not documented in the account's investigation of the incident.The hillrom technician that inspected the bed found the bed exit would set, but the external speaker would only make a low tone that could not be heard.The account has ordered the external speaker and will replace it when received.Based on this information, no further action is required.

Event Description

Hillrom received a report from the account stating the patient was found on the floor by the bed.The patient complained initially of shoulder pain and later of hip pain.The account performed x-rays of the patient's left clavicle and left hip to confirm they were fractured.The bed was located in the patient room at the account.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: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 8649405
• MDR Text Key: 146348503
• Report Number: 1824206-2019-00221
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/14/2019

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: P3200K000019
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2014
• 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: 78 YR
• Patient Weight: 42