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

Model Number P1600C005441

Device Problem Insufficient Information (3190)

Patient Problem Limb Fracture (4518)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

The customer reported that while the patient was sleeping, the patient got her arm and wrist caught in the side rail of the bed causing a fracture.Multiple attempts to obtain additional details of the event including the location of the fracture and medical intervention provided in order to determine the severity of the injury have been unsuccessful.In addition, it could not be confirmed that a hillrom bed was in use at the time of the event.It is noted that the customer stated ¿i do not have manufacturer numbers or models regarding this event.We have multiple types of beds in house.In addition, the information of the bed was not saved at the time of the event, and we do not have a way to track which bed it was in retrospect.Treatment of a fracture depends on the extent of the break, small breaks or those with good overall alignment are often treated non-surgically with a combination of medication, immobilization, and rehabilitation.However, more extensive fractures usually require surgery.Based on the details provided, a serious injury could not be ruled out, nor could it be ruled out that a hillrom bed didn¿t cause or contribute to the possible serious injury.Therefore, hillrom is conservatively reporting this event.Per the hillrom service manual the advanta bed requires an effective maintenance program.Preventative maintenance will minimize downtime due to excessive wear.Test the side rail for proper latching.As no serial number was provided for this bed, a search of the hillrom maintenance records for any hillrom performed preventative maintenance on this bed was unable to be completed.It is unknown if the facility performs preventative maintenance on their beds.The technician was unable to inspect the bed due to the facility being unsure of what bed the patient was on.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the patient got her arm and wrist caught in the siderail causing a fracture.The bed was located at the account.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: ADVANTA 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: 11957460
• MDR Text Key: 254854591
• Report Number: 1824206-2021-00285
• 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: 06/08/2021

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: P1600C005441
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: No
• 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