InjuryDRN
EECP
Received Mar 3, 2016 · Event occurred Jan 13, 2016
Report MW5060782 · MDR key 5486213
Device
Product problems
- Insufficient Device Problem Information
Patient
86 YR
- Hematoma
- Hematoma
Narrative
Description of Event or Problem
PATIENT EXPERIENCED A HEMATOMA ON HIS COCCYX AFTER AN EECP TREATMENT (29TH OUT OF 35 PLANNED TREATMENTS). MANUFACTURER, VASOMEDICAL, INSPECTED DEVICE ON (B)(6) 2016. DEVICE WAS TESTED ACCORDING TO COMPLETE PREVENTATIVE MAINTENANCE PROCEDURES, AND NO PROBLEMS WERE FOUND. AFTER NURSE MANAGER CONSULTED WITH PATIENT IN (B)(6), IT APPEARS THERE WERE OTHER MITIGATING FACTORS THAT COULD LIKELY HAVE CONTRIBUTED TO PATIENT'S INJURY (LOW HR, SKIN FRAGILITY, PATIENT'S CHOICE OF POSITIONING ON THE TABLE).