ENCHANCED EXTERNAL COUNTERPULSATION
Received Nov 5, 2007 · Event occurred Oct 15, 2007
Report 2435300-2007-00002 · MDR key 938464
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
87 YR
- Improved patient condition
- Breathing difficulties
- Low Oxygen Saturation
- Therapy/non-surgical treatment, aborted/stopped
- Heart rate, increased
- Treatment with medication(s)
- Hospitalization required
Narrative
Description of Event or Problem
FOURTY FOUR MINUTES INTO 2ND TREATMENT SESSION, PT HR INCREASED TO 132 BPM, O2 DROPPED TO 65%, C/O SOB, DENIED CP. TREATMENT STOPPED, ONE NITRO TAB GIVEN, HR DECREASED TO 97 BPM, O2 CONTINUED TO DROP. SECOND NTG GIVEN, O2 INCREASED. O2 VIA NASAL CANNULA GIVEN, O2 INCREASED AND PT REPORTED FEELING BETTER. PT TRANSFERRED TO ER.
Additional Manufacturer Narrative
AFTER FIRST TREATMENT SESSION IN 2007, DR DISCONTINUED LASIX AND INCREASED TOPRAL. INSTRUCTED PATIENT TO REDUCE FLUIDS AND MONITOR WEIGHT. THREE DAYS LATER, PATIENT HAD ONE POUND WEIGHT GAIN, WAS CLEARED FOR SECOND TREATMENT SESSION. DR BELIEVES MEDICATION CHANGE CONTRIBUTED TO ADVERSE EVENT.