MAUDE Adverse Event Report: BELIMED AG CS750 CLEAN STATION; WASHER OF BODY WASTE RECEPTACLES

Model Number CS750

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

Analysis of the data log revealed that the hospital-designated professional cssd operators repeated the following sequence of actions a total of 123 times over a period of three weeks and four days prior to the incident: on the occasions when the washer doors did not close properly due to slightly misaligned door guides, activating the system warning signal and error message, the operator selected the command to override the warnings; the door closed, either on its own or by application of manual force, and the washing process was conducted as specified.On additional occasions, the doors closed correctly and no error message nor warning signal was displayed by the device.On (b)(6) 2017, the door again became stuck.The operator on duty reached in to forcefully close the door by pulling it.It slammed shut and her hand was injured.The device is provided with a clear warning label with regard to the danger of suffering hand injuries by crushing if a hand is introduced between the moving parts of the door, i.E., when the door is activated to be closed or when opening.This warning is also included in the operating instructions and the danger is discussed during distributor-conducted training of the hospital employees.These warnings were ignored by the operator who suffered the injury.In addition, both during training and in the operating instructions it is clearly stated that whenever a warning signal and a warning message are displayed on the machine and the control panel, the device may not be used and the supervisor must be informed immediately in order to initiate the troubleshooting procedure and have the failure remedied by qualified professional service personnel, if required.In accordance with the information recorded on the data log, these instructions were ignored a total of 123 times.The problem directly leading to the injury is therefore user error / misuse.The door guides were realigned on may 24, 2017, and the device is functioning properly.

Event Description

The operator of the washer attempted to close the washer door by means of the appropriate control.When it did not close she reached in to forcefully pull it shut, breaking a bone in her hand.She was taken to er and her hand was placed in a cast.

• Brand Name: CS750 CLEAN STATION
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer (Section G): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer Contact: stefan roemer ; grienbachstrasse 11; zug, zug 6300 ; SZ 6300 ; 414497888
• MDR Report Key: 6629116
• MDR Text Key: 77424174
• Report Number: 3001061128-2017-00001
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CS750
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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