MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-09 for CS750 CLEAN STATION manufactured by Belimed Ag.
[77424174]
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.
Patient Sequence No: 1, Text Type: N, H10
[77424175]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001061128-2017-00001 |
| MDR Report Key | 6629116 |
| Date Received | 2017-06-09 |
| Date of Report | 2017-06-09 |
| Date of Event | 2017-05-10 |
| Date Mfgr Received | 2017-05-12 |
| Device Manufacturer Date | 2016-02-18 |
| Date Added to Maude | 2017-06-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STEFAN ROEMER |
| Manufacturer Street | GRIENBACHSTRASSE 11 |
| Manufacturer City | ZUG, ZUG 6300 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6300 |
| Manufacturer Phone | 414497888 |
| Manufacturer G1 | BELIMED AG |
| Manufacturer Street | GRIENBACHSTRASSE 11 |
| Manufacturer City | ZUG, ZUG 6300 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CS750 CLEAN STATION |
| Generic Name | WASHER OF BODY WASTE RECEPTACLES |
| Product Code | FLH |
| Date Received | 2017-06-09 |
| Model Number | CS750 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BELIMED AG |
| Manufacturer Address | GRIENBACHSTRASSE 11 ZUG, ZUG 6300 SZ 6300 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-09 |