ENHANCED EXTERNAL COUNTERPULSATION
Received Jan 11, 2007 · Event occurred Dec 26, 2006
Report 2435300-2007-00001 · MDR key 805272
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
56 YR
- Breathing difficulties
- Treatment with medication(s)
- Hospitalization required
Narrative
Description of Event or Problem
PATIENT REPORTED SWELLING IN BOTH FEET AND ANKLES IN 2006. NO SWELLING EVIDENT PRE-EECP TREATMENT THE NEXT DAY. ALSO, LUNGS WERE CLEAR, NO APPARENT WEIGHT GAIN. PATIENT HAD BEEN STARTED ON ACTOSE. PATIENT RECEIVED 45 MINUTES OF TREATMENT SESSION 33 WHEN HE BECAME SHORT OF BREATH. TREATMENT DISCONTINUED AND TRANSFERRED TO ED. GIVEN LASIX RESULTING IN 4000CC FLUID EXCRETION. PATIENT FELT FINE BUT ADMITTED OVERNIGHT FOR OBSERVATION. PATIENT DISCHARGED HOME THE NEXT DAY.
Additional Manufacturer Narrative
ALTHOUGH THERE ARE CLEAR EXTENUATING CIRCUMSTANCES LEADING TO THIS EVENT, THERE IS EVIDENCE TO SUGGEST THAT THE DEVICE CONTRIBUTED TO THIS SERIOUS EVENT.