FDA Adverse Event
Malfunction
Summary report: N
SERVO DUO GUARD
MDR report key: 8943558
·
Received August 29, 2019
Report
- Report Number
- 8010042-2019-00627
- Event Type
- Malfunction
- Date Received
- August 29, 2019
- Date of Event
- July 17, 2019
- Report Date
- February 21, 2020
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CAH
- PMA / PMN Number
- K030071
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS A DUPLICATE OF MFG REPORT NUMBER: 8010042-2019-00570.
Description of Event or Problem · 0
MANUFACTURER'S REF : 241401.
Description of Event or Problem · 1
IT WAS REPORTED DURING CONNECTING TO THE PATIENT CIRCUIT, THE BACTERIA FILTER BECAME SEPARATED IN TWO PARTS. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF : (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 737123 | SERVO DUO GUARD | FILTER, BACTERIAL, BREATHING-CIRCUIT | CAH | MAQUET CRITICAL CARE AB | SERVO DUO GUARD | 01803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |