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

Model Number P1170GHPG0001

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the nurse call membranes and caregiver control membranes on the right and left head siderails needed to be replaced.Per the hill-rom 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.Sidecom® communication system: inspect and test the communication junction box.Make sure the sidecom® communication system features operate correctly.Inspect the communication cable, including the male and female pins in the plug.Replace as necessary.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in november 2018.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the nurse call membranes and caregiver control membranes on the right and left head siderails to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from a hill-rom technician stating the bed's nurse call was not working from the right or left head siderails.The bed was located in room 4124 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, NUL
• 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: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 8115693
• MDR Text Key: 128880162
• Report Number: 3006697241-2018-00104
• 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: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P1170GHPG0001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2010
• 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