FDA Adverse Event
Death
Summary report: N
SIRECUST 455
MDR report key: 307034
·
Received December 1, 2000
Report
- Report Number
- 1220063-2000-00031
- Event Type
- Death
- Date Received
- December 1, 2000
- Date of Event
- November 14, 2000
- Report Date
- November 29, 2000
- Manufacturer
- SIEMENS MEDICAL SYSTEMS INC. EM-PCS
- Product Code
- DRT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
FAILURE DESCRIPTION: 1. NO DATA TRANSMISSION, 2. PT BEDS WITH WRONG ID NUMBERS, 3. NO ALARM TRANSMISSION TO THE CENTRAL STATION. NO ASYSTOLIC ALARM WAS TRANSMITTED TO THE CENTRAL STATION. BECAUSE OF THIS, THE NURSE COULD NOT PROMPTLY INITIATE RESUSCITATION AND THE PT DIED. THE CANNON STRIPS OF THE SIRECUST 400'S SYSTEM INTERFACE BOARDS ARE TOO LOW IN THE ICU BAR. THIS CAUSES A PROBLEM WITH THE CABLES CONNECTING TO THE WALL. SOMETIMES THEY MAKE CONTACT, SOMETIMES THEY DON'T. THE HOSP NEEDS HELP WITH 16 PT BEDS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIRECUST 455 | CENTRAL PATIENT MONITORING DEVICE | DRT | SIEMENS MEDICAL SYSTEMS INC. EM-PCS | 7368418E2265 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death| O |