FDA Adverse Event
Other
Summary report: N
MULTIVIEW WORKSTATION WITH CRS OPTION
MDR report key: 585431
·
Received March 21, 2005
Report
- Report Number
- 1220063-2005-00003
- Event Type
- Other
- Date Received
- March 21, 2005
- Date of Event
- February 12, 2003
- Report Date
- March 1, 2005
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC.
- Product Code
- DRT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
TWO DIFFERENT PATIENTS GOT THEIR ECG STORED ON THE LAST PATIENT'S IDENTITY IN THE MULTIVIEW WORKSTATION WITH CRS (CARDIAC REVIEW STATION) OPTION. THE FIRST PATIENT'S ECG SHOWS CHANGES, WHICH SHOULD LEAD TO AN ANGIOGRAPHY IF IT HAD BEEN THE LAST PATIENTS ECG. THIS WAS DISCOVERED BEFORE ANY PREVENTIVE ACTIONS. THE CUSTOMER'S CERTIFIED BIOMEDICAL ENGINEER'S FURTHER COMMENTS: THE REASON FOR THIS FAULT IS THAT FIRST PATIENT WASN'T DISCHARGED FROM THE SYSTEM BEFORE LAST WAS CONNECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTIVIEW WORKSTATION WITH CRS OPTION | CENTRAL STATION PATIENT MONITOR | DRT | DRAEGER MEDICAL SYSTEMS, INC. | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |