ARGUS PB-1000
Report
- Report Number
- 3002808182-2024-72393
- Event Type
- Malfunction
- Date Received
- October 30, 2024
- Date of Event
- July 1, 2024
- Report Date
- October 30, 2024
- Manufacturer
- SCHILLER AG
- Product Code
- MHX
- UDI-DI
- 00761335000085
- PMA / PMN Number
- K012226
- Removal / Correction Number
- 0301190000-2024-8016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
SCHILLER AG HAS RECEIVED THE REPORT 0301190000-2024-8016, ACCORDING TO WHICH: "SYSTEM DISPLAYED INABILITY TO RELIABLY ACQUIRE AND PRODUCE REALISTIC HEMODYNAMIC VALUES. HEART RATE (HR) PER MERGE IS INACCURATE READING 0 TO LOW 20S. CHANGED AND ALTERNATED LEADS TO FIND HR UNSUCCESSFULLY. CHANGED THE HR TO BE FROM THE O2 SENSOR AND HAD ACCURATE HR. WHEN SWITCHING TO O2 SENSING LOST THE ABILITY TO CALCULATE AORTIC PRESSURES. COULD VISUALLY SEE THE PRESSURES BUT SYSTEM UNABLE TO CALCULATE FOR THE REPORT."
SCHILLER AG HAS RECEIVED THE REPORT 0301190000-2024-8016, ACCORDING TO WHICH: "SYSTEM DISPLAYED INABILITY TO RELIABLY ACQUIRE AND PRODUCE REALISTIC HEMODYNAMIC VALUES. HEART RATE (HR) PER MERGE IS INACCURATE READING 0 TO LOW 20S. CHANGED AND ALTERNATED LEADS TO FIND HR UNSUCCESSFULLY. CHANGED THE HR TO BE FROM THE O2 SENSOR AND HAD ACCURATE HR. WHEN SWITCHING TO O2 SENSING LOST THE ABILITY TO CALCULATE AORTIC PRESSURES. COULD VISUALLY SEE THE PRESSURES BUT SYSTEM UNABLE TO CALCULATE FOR THE REPORT.".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1890778 | ARGUS PB-1000 | ARGUS PB-1000 | MHX | SCHILLER AG | 3.920978 | 00761335000085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male |