FDA Adverse Event
Malfunction
Summary report: N
FLOCARE INFINITY 2 PUMP
MDR report key: 2251605
·
Received August 30, 2011
Report
- Report Number
- 1722139-2011-00282
- Event Type
- Malfunction
- Date Received
- August 30, 2011
- Date of Event
- December 3, 2009
- Report Date
- December 21, 2009
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- LZH
- PMA / PMN Number
- K031199
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO EVIDENCE OF FIRE WAS FOUND. THE PCB WAS CHARRED AROUND A DIODE. THE AC ADAPTOR WAS RETURNED TO THE MFR FOR ANALYSIS WHO FOUND A LOOSE CONNECTION BETWEEN A RESISTOR AND SOLDER PAD, WHICH MAY BE A RESULT OF MECHANICAL STRESS AFTER MANY YEARS IN THE FIELD. THE CONSTANT HIGH VOLTAGE ON THESE PARTS CAUSED EXCESSIVE POWER DISSIPATION BY THE DIODES WHICH RESULTED IN OVERHEATING, BURNING THE PUMP PCB AND MELTING THE KEYPAD. THIS MDR IS BEING FILED AS PART OF THE RETROSPECTIVE REVIEW FOR REPORTABILITY.
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THE PUMP CAUGHT FIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLOCARE INFINITY 2 PUMP | LZH | MOOG MEDICAL DEVICES GROUP | INFINITY PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Disability |