FDA Adverse Event
Malfunction
Summary report: N
OPTIVANTAGE WITH CEILING SUSPENSION
MDR report key: 1188348
·
Received October 3, 2008
Report
- Report Number
- 1518293-2008-00306
- Event Type
- Malfunction
- Date Received
- October 3, 2008
- Date of Event
- September 5, 2008
- Report Date
- September 5, 2008
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- IZQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURING INVESTIGATION PENDING. UPON RECEIPT OF THE INVESTIGATION SUMMARY, A MEDWATCH 3500 SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IN 2008: CUSTOMER (ENGINEER): DURING USE OF THE CONTRAST MEDIA PUMP, AIR EMBOLISMS HAPPENED REPEATEDLY. ORIGINAL EQUIPMENT WAS USED ACCORDING TO INSTRUCTION AND IFU (INFO FOR USE). WE NOTICED DURING SINGLE CONTRAST MEDICAL EXAMINATIONS, ISOLATED SMALL AND BIG INTRAVASAL AIR BUBBLES, WHICH WHERE INJECTED THROUGH THE CONTRAST MEDIA INJECTOR INTO THE VASCULAR SYSTEM OF THE PATIENTS. NO PATIENT INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTIVANTAGE WITH CEILING SUSPENSION | CT POWER INJECTOR SYSTEM | IZQ | LIEBEL-FLARSHEIM CO. | OPTIVANTAGE DH | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |