MAUDE Adverse Event Report: HILL-ROM MEXICO ADVANTA 2 FRAME; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number P1190A000142

Device Problem Self-Activation or Keying (1557)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the left side rail cable needed to be replaced.Per the hill-rom service manual the advanta¿ 2 should be subject to an effective maintenance program.This will help make sure of a long, operative life for the advanta¿ 2 bed.The preventative maintenance will help to reduce downtime due to excessive wear failures.An annual service of the bed is advised in order to maintain its characteristics and performance.Make sure that the controls are in good condition and that the membranes are not worn or torn.Make sure that the bed does not fail any of the function checks.Replace or repair parts as 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 left side rail cable 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 was raising on its own.The bed was located at the account.There was no patient/user injury reported.(b)(4).

• Brand Name: ADVANTA 2 FRAME
• 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: erin padgett ; 1069 state route 46 east; batesville, IN 47006 ; 8129312791
• MDR Report Key: 7706340
• MDR Text Key: 114812518
• Report Number: 3006697241-2018-00058
• 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: 07/06/2018

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: P1190A000142
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2012
• 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