inforMED
MalfunctionBZM

MEDGRAPHICS PULMONARY FUNCTION

Received Apr 16, 2007 · Event occurred Jan 23, 2007

Report MW5001815 · MDR key 839713

Device

Generic name

None

Model number

1085

Lot number

3001119

Product problems

  • Measurements, inaccurate
  • Interference

Patient

YR

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

DURING GAS CHROMATOGRAPH MEASUREMENT OF STUDY, PATIENT'S CELL PHONE RANG. INTERFERED WITH GAS MEASUREMENT, CAUSED SPIKES, CAUSED PREMATURE END OF MEASUREMENT, AND RESULTED IN MEASUREMENT OF 299% OF PREDICTED VALUE FOR STUDY. TEST REPEATED WITH CELL PHONE TURNED OFF, NO FURTHER COMPLICATIONS. ANOMALY WAS RELIABLY REPRODUCED USING A NEXTEL BRAND CELL PHONE -SAME BRAND AS PATIENT. ANOTHER TYPE OF CELL PHONE WAS ALSO CHECKED BUT DID NOT REPRODUCE THIS ANOMALY.