FDA Adverse Event
Malfunction
Summary report: N
MAQUET SAS
MDR report key: 3022539
·
Received March 20, 2013
Report
- Report Number
- 9710055-2013-00010
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- February 8, 2013
- Report Date
- February 20, 2013
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K040735
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
A MAQUET AUTHORIZED TECHNICIAN INSPECTED THE DEVICE. THE TECHNICIAN REMOVED ANY REMNANTS OF PAINT AT THIS JUNCTURE AND VERIFIED THAT NO FURTHER ABRASION IS OCCURRING. THIS INVESTIGATION IS ON-GOING AND THE RESULTS WILL BE INCLUDED IN A FOLLOW UP REPORT. EXEMPTION # (B)(4). MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.
Description of Event or Problem · 1
MAQUET SERVICE FOUND DEVICE HAD PAINT PARTICLES FALLING FROM THE JUNCTION BETWEEN THE SPRING ARM AND THE SINGLE FORK BRACKET. NO INJURIES WERE REPORTED BY THE HOSPITAL. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115849 | MAQUET SAS | FSY | MAQUET SAS | X10 SF DUO LD | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |