FDA Adverse Event
Malfunction
Summary report: N
PRISMAFLEX SYSTEM
MDR report key: 776350
·
Received September 7, 2006
Report
- Report Number
- 9616026-2006-00305
- Event Type
- Malfunction
- Date Received
- September 7, 2006
- Date of Event
- August 20, 2006
- Report Date
- August 20, 2006
- Manufacturer
- GAMBRO LUNDIA AB, MONITOR DIVISION
- Product Code
- KDI
- PMA / PMN Number
- K041005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO PATIENT INJURY OR CLINICAL CONSEQUENCES TO THE PATIENT REPORTED. GAMBRO RENAL PRODUCTS HAS REQUESTED THE DOWNLOADED MACHINE DATA FILES, THE FAULTY POWER SUPPLY, AND ADDITIONAL INFORMATION RELATING TO THIS INCIDENT. FURTHER INVESTIGATION IS BEING CONDUCTED BY THE MANUFACTURER. THE COMPANY IS AWARE OF THIS MACHINE MALFUNCTION (POWER SUPPLY FAILURE) AND IS WORKING ON CORRECTIONS. WE WILL PROVIDE A REPORT ON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
CUSTOMER REPORTED AN INCIDENT WITH A POWER SUPPLY FAILURE DURING TREATMENT. LOUD BANG HEARD FROM THE PRISMAFLEX MACHINE AND THEN THE MACHINE TURNED OFF. CUSTOMER UNABLE TO TURN MACHINE BACK ON. NO ERROR CODES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRISMAFLEX SYSTEM | INTENSIVE CARE HEMODIALYSIS | KDI | GAMBRO LUNDIA AB, MONITOR DIVISION | 107493 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |