FDA Adverse Event
Malfunction
Summary report: N
ARGUS PB-1000
MDR report key: 21384079
·
Received February 14, 2025
Report
- Report Number
- 3002808182-2025-00019
- Event Type
- Malfunction
- Date Received
- February 14, 2025
- Date of Event
- January 6, 2025
- Report Date
- June 11, 2025
- Manufacturer
- SCHILLER AG
- Product Code
- MHX
- UDI-DI
- 07613365000085
- PMA / PMN Number
- K012226
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 0
ON 01/17/2025 IT WAS REPORTED TO SCHILLER AG THAT THE PB-1000 WHICH WAS USED IN A HOST SYSTEM IN A CATH LAB SEEM TO HAVE MALFUNCTIONNED. UPON MULTIPLE ECG RESETS, LEAD II REMAINED A FLAT LINE.
Description of Event or Problem · 0
ON (B)(6) 2025 IT WAS REPORTED TO SCHILLER AG THAT THE PB-1000 WHICH WAS USED IN A HOST SYSTEM IN A CATH LAB SEEM TO HAVE MALFUNCTIONNED. UPON MULTIPLE ECG RESETS, LEAD II REMAINED A FLAT LINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 982406 | ARGUS PB-1000 | PB-1000 | MHX | SCHILLER AG | 3.920948 | 07613365000085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |