FDA Adverse Event
Malfunction
Summary report: N
MASS SPECTROMETER, CLINICAL USE
MDR report key: 19381742
·
Received May 23, 2024
Report
- Report Number
- 3009715051-2024-00001
- Event Type
- Malfunction
- Date Received
- May 23, 2024
- Date of Event
- April 27, 2024
- Report Date
- May 23, 2024
- Manufacturer
- AB SCIEX PTE. LTD.
- Product Code
- DOP
- Removal / Correction Number
- Z-0037-2024, Z-0038-2024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE PRODUCT INVOLVED IN THE INCIDENT IS NOT A MEDICAL DEVICE. HOWEVER, IT CAN BE CONSIDERED TO BE SIMILAR TO SCIEX'S MARKETED MASS SPECTROMETERS AS THEY SHARE DESIGN CHARACTERISTICS AND COMPONENTS. AS A RESULT, THE MALFUNCTION MAY OCCUR WITH SCIEX'S MEDICAL DEVICES WITH A REMOTE PROBABILITY OF A SERIOUS INJURY. A CORRECTION FOR SIMILAR MEDICAL DEVICES HAS BEEN IN PROCESS IN THE US AS REFERENCED IN SECTION H9 (Z-0037-2024, Z-0038-2024, Z-0039-2024, Z-0040-2024).
Description of Event or Problem · 0
ELECTRODE ADJUSTMENT NUT ON THE PROBE ASSEMBLY OF THE MASS SPECTROMETER WAS FOUND BURNT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584303 | MASS SPECTROMETER, CLINICAL USE | DOP | AB SCIEX PTE. LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |