FDA Adverse Event Injury Summary report: N

ZOLL PACING WAVEFORM

MDR report key: 2112876 · Received May 26, 2011

Report

Report Number
MW5020787
Event Type
Injury
Date Received
May 26, 2011
Date of Event
May 3, 2011
Report Date
May 25, 2011
Manufacturer
BIO-DETEK, INC.
Product Code
MLN
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MT, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

THIS INCIDENT OCCURRED ON (B)(6). THE PT ARRIVED IN ICU WITH PROFOUND BRADYCARDIA (HR 30) AND WAS PLACED ON OUR ZOLL MONITOR AND TRANSCUTANEOUS PACING INITIATED FROM 1800 - 2145. THE CARDIOLOGIST ATTEMPTED TO PLACE A TEMPORARY TRANSVENOUS CATHETER AT THE BEDSIDE AROUND 2100, BUT COULD NOT GET THE CATHETER PLACED, SO THE PT WENT TO THE CATH LAB FOR PLACEMENT. TOTAL HOURS FOR TRANSCUTANEOUS PACING WAS APPROX 3 - 4 HOURS. THE MA WAS SET AT 60 AND THE RATE AT 70 TO OBTAIN CAPTURE TO SUSTAIN A SYSTOLIC BP OF >100. ONCE THE TRANSCUTANEOUS CATHETER WAS IN PLACE AND CAPTURING, THE EXTERNAL WAS DISCONTINUED. THE ACTUAL ELECTRODE WAS NOT REMOVED UNTIL THE NEXT AM AT WHICH TIME THE RN NOTED 4 - 5 SMALL RED BLISTERS WITH DARK EDGES UNDER THE ELECTRODE. THE RN STATED THAT THE ELECTRODE HAD GOOD CONTACT WITH NO PEELING EDGES OR POINTS OF LACK OF SKIN CONTACT. THESE BLISTERS WERE ON THE ANTERIOR ELECTRODE. NO SKIN ISSUES UNDER THE POSTERIOR PAD. THE ZOLL MONITOR WAS SEQUESTERED. THE ORIGINAL PACKAGE THAT THE ELECTRODES CAME IN WAS NOT SAVED, AS NO ONE KNEW OR ANTICIPATED ANY ISSUES WITH THIS PACING EPISODE. THE ZOLL MONITOR WAS EVALUATED BY THE CLINICAL ENGINEERING DEPT AT BENEFITS AND FOUND TO BE WORKING PROPERLY. THE MONITOR WAS THEN SENT TO ZOLL FOR EVAL AND TESTING PER THEIR REQUEST.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ZOLL PACING WAVEFORM ZOLL ELECTRODE MLN BIO-DETEK, INC.

Patients

Seq Age Sex Outcome Treatment
1 85 YR Other