FDA Adverse Event
Malfunction
Summary report: N
PE SAHARA CE W/VALVE
MDR report key: 384127
·
Received March 21, 2002
Report
- Report Number
- 1221601-2002-00006
- Event Type
- Malfunction
- Date Received
- March 21, 2002
- Report Date
- March 21, 2002
- Manufacturer
- GENZYME BIOSURGERY A DIVISION OF GENZYME
- Product Code
- KDQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER ALLEGES THAT AFTER THE COLLECTION CHAMBER FILLS COMPLETELY, THE AIRLEAK MEASUREMENT FILLS WITH WATER. THE CUSTOMER ALLEGES THAT BODYFLUID IS GETTING SUCKED INTO THE WALL SUCTION WHEN THE UNIT IS FULL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PE SAHARA CE W/VALVE | CHEST DRAINAGE DEVICE | KDQ | GENZYME BIOSURGERY A DIVISION OF GENZYME | S-1100A-08 | 513800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |