DeathDRN
ENHANCED EXTERNAL COUNTERPULSATION
Received Apr 21, 2005 · Event occurred Feb 8, 2005
Report 2435300-2005-00002 · MDR key 594554
Device
Generic name
Device, External, Counter Pulsating
Manufacturer
Vasomedical, Inc.Model number
TS3Catalog number
*
Lot number
*
Product problems
- Unknown (for use when the device problem is not known)
Patient
72 YR
- Cardiac Arrest
- Chest Pain
- Death
- Pulmonary Edema
- Respiratory Distress
- Heart Failure
- Resuscitation
- Therapy/non-surgical treatment, aborted/stopped
- Treatment with medication(s)
- Hospitalization required
Narrative
Description of Event or Problem
NINE MINUTES INTO PATIENT'S FIRST TREATMENT SESSION, PATIENT, DEVELOPED ACUTE ONSET OF SHORTNESS FOR BREATH AND CHEST PAIN. THE TREATMENT WAS STOPPED, PHYSICIAN WAS CALLED, IV STARTED, 02 GIVEN, IV MORPHINE AND LASIX GIVEN, EMS CALLED. PATIENT CODED AND REQUIRED RESUSCITATION EN ROUTE. RESUSCITATION EFFORTS CONTINUED UNTIL ER. ADMITTED WITH CHF AND PULMONARY EDEMA. PATIENT EXPIRED EIGHT DAYS LATER WHILE STILL AN IN-PATIENT.