MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Device Problem Failure to Capture (1081)

Patient Problems Dizziness (2194); Diminished Pulse Pressure (2606)

Event Date 03/26/2021

Event Type  Injury  

Event Description

Attempted transcutaneous pacing using zoll one step cpr complete pads and r series.Unable to obtain capture.Pt's heart rate 30s, symptomatic: dizzy, pacer rate set at 70bpm, mas attempted between 40 and 80 mas with no visible electronic capture, no change in natural monitored heart rate or palpated pulse rate, and no physical signs or symptomatic of capture.Unsuccessful troubleshooting: checked cable and pad placement (used roll technique).R-series on pace mode (green) and plugged in.Replaced pad cable.Added electrode placement (and changed cord), pt given atropine with favorable response and transferred to (b)(6).Further testing completed on test boxes and manikin with more than one r-series producing varied inconsistent results.Unpredictable intermittent capture.Highly positionally dependent results.

• Brand Name: R SERIES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION ; 269 mill rd; chelmsford MA 01824 4105
• MDR Report Key: 11731419
• MDR Text Key: 247695102
• Report Number: MW5100984
• Device Sequence Number: 4
• Product Code: MKJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 04/06/2021
• 9 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 74 YR
• Patient Weight: 86