MAUDE Adverse Event Report: HILL-ROM MEXICO CAREASSIST ES; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P1170G0000319

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the brake casters 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.Brake casters should be checked for cuts, wear and quality of tread, etc.And replaced when necessary.Examine the brakes to see whether the bed moves when the brake are set.Replace as necessary.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in august 2018.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the brake casters to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from a hill-rom service technician stating the casters were rolling with the brakes set.The bed was located at the account.There was no patient/ user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: CAREASSIST ES
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon 66640 ; MX 66640
• Manufacturer Contact: emily mitchell ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 8196046
• MDR Text Key: 131496525
• Report Number: 3006697241-2018-00111
• 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: 12/11/2018

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: Other
• Device Model Number: P1170G0000319
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2010
• 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