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

Model Number P1600A000001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

The night shift maintenance staff member fractured a finger that required immobilization with a cast.Medical intervention was provided to prevent permanent impairment of the finger and therefore meets the criteria as a serious injury.The bed did not malfunction, the user was moving the bed to an outlet, that was on a slope.The user caught their hand between the wall and the bed, resulting in a fracture.The hill-rom technician thoroughly inspected the bed and found no malfunctions.The bed functioned as designed.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating that a night shift maintenance staff member was moving the bed and caught his hand between the bed and the wall.The night shift maintenance staff member broke his finger.The bed was located in a patient room in the storage area of 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: emily mitchell ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 8507110
• MDR Text Key: 141724059
• Report Number: 1824206-2019-00146
• Device Sequence Number: 0
• Product Code: FNL
• 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: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: P1600A000001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1