MAUDE Adverse Event Report: HILL-ROM BATESVILLE VERSACARE FRAME; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number P3200J000402

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Fall (1848)

Event Date 05/07/2018

Event Type  Injury  

Manufacturer Narrative

The hill-rom technician thoroughly inspected all bed functions and could not duplicate the unintentional movement of the bed.No malfunction was identified with the bed and it functioned as designed.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the patient was being assisted out of the bed when the bed unintentionally raised.The account alleged the patient fell and required surgery.The account could not confirm the exact date or location of the incident.Hill-rom contacted the account three times to obtain information about the alleged injury.No response has been received from the account.This report was filed in our complaint handling system as (b)(4).

• Brand Name: VERSACARE FRAME
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• 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: 7569694
• MDR Text Key: 110093196
• Report Number: 1824206-2018-00214
• 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: Hospital Service Technician
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P3200J000402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2010
• 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