MAUDE Adverse Event Report: HILL-ROM MEXICO CAREASSIST ES; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number P1170G0000454

Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the hand pendant on the bed 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.Patient pendant: disconnect the patient pendant and check the condition of the connector.Then reconnect or replace the pendant.Test each of the buttons to check that they activate the correct function and that they do not work intermittently by pressing each button for several seconds.Each movement must be continuous.Replace the pendant if necessary.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 technician replaced the hand pendant 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 bed's head section goes up automatically by itself and will not go down when pressing the head down button.The bed was located at the account.There was no patient/user injury reported.(b)(4).

• Brand Name: CAREASSIST ES
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• 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: 7297519
• MDR Text Key: 101131633
• Report Number: 3006697241-2018-00018
• 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: 02/05/2018

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: P1170G0000454
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• 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