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

Model Number P3201K000495

Device Problem Self-Activation or Keying (1557)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

The distributor's service engineer found the left and right foot control assemblies needed to be replaced.Per the hill-rom service manual, perform annual preventive maintenance procedures to make sure all versacare® bed components are functioning as originally designed.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The engineer replaced the left and right foot control assemblies to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the head of the bed would go up on its own.The bed was located at the account.There was no patient/user injury reported.(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: 7623312
• MDR Text Key: 111991839
• Report Number: 1824206-2018-00241
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P3201K000495
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• 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