MAUDE Adverse Event Report: HILL-ROM MEXICO CAREASSIST ES155/255/455; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P1170G0000154

Device Problem Device Slipped (1584)

Patient Problem No Patient Involvement (2645)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the brake caster needed to be replaced.Per the hillrom service manual the bed should be subject to an effective maintenance program.An annual service of the bed is advised in order to maintain its characteristics and performance.Brake casters should be checked for cuts, wear and quality of tread, etc.And replaced when necessary.Check the brakes to see whether the bed moves when the brake pedals are pressed and repair as necessary.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the brake caster to resolve the issue.Based on this information, no further action is required.

Event Description

Hillrom received a report from the hillrom service technician stating the brakes would set but would not hold.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 ES155/255/455
• 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: 8945381
• MDR Text Key: 156007678
• Report Number: 3006697241-2019-00067
• 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: 08/14/2019

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?: No
• Device Operator: No Information
• Device Model Number: P1170G0000154
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2010
• 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