EXCEL
Received Dec 14, 2002 · Event occurred Sep 20, 2002
Report 432686 · MDR key 432686
Product problems
- Shock, electrical
- Unknown (for use when the device problem is not known)
Patient
44 YR
- Shock
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
PHYSICAL THERAPIST REPORTED PATIENT EXPERIENCED A "SHOCK" AS THERAPIST WAS ADMINISTERING AN ULTRASOUND TREATMENT TO PATIENT'S LEFT ANTERIOR SHOULDER.
Description of Event or Problem
ADD'L INFO RECEIVED FROM MFR 2/3/03: MODEL NUMBER: 3000. CATALOG NUMBER: PART NUMBER 0998-00-0077-15. LOT NUMBER: NA. THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT DURING A PULMONARY ANGIOGRAM, THE UNIT'S DISPLAY BLACKED OUT SEVERAL TIMES. THEY WERE UNABLE TO RUN PULMONARY READING RECORDER STRIPS. THE PT WAS SWITCHED TO ANOTHER UNIT AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED. DATASCOPE WAS NOT ADVISED OF THE EVENT UNTIL FOUR MONTHS AFTER IT HAD OCCURRED. AT THAT TIME, FOLLOW-UP PHONE CALLS TO THE GE CLINICAL SERVICES BIOMEDS WHO TYPICALLY MAINTAIN THE MONITOR, AND RISK MGMT (ALSO THE MEDWATCH CONTACT PERSON), DETERMINED THAT THE SITE HAD ELECTED TO RETIRE THE MONITOR FROM USE, BASED UPON ITS AGE. IT WAS TEN YEARS OLD AT THE TIME OF THE EVENT. THE DEIVCE HAS BEEN RETIRED FROM USE BY THE SITE.