MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL ONE STEP CPR COMPLETE PADS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Lot Number UNAVAILABLE

Device Problem No Pacing (3268)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762)

Event Date 03/06/2021

Event Type  Injury  

Event Description

Attempted transcutaneous pacing using zoll one step cpr complete pads with r series after atropine was unsuccessful in the field for symptomatic bradycardia - hr 20's, low bp gcs3, r series on pacer mode, rate set at 70 bpm, 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 of capture.Troubleshooting: changed pads, condition deteriorated, cpr performed, transvenous pacemaker inserted and successfully paced the pt.Transferred to another facility.No lot number to report on the one step pads.Witnessed cardiac arrest pta - initial rhythm bradycardia.O2, lvf, atropine, paced pta, preceding 'sx' cp, sob, dizzy, decompensated during long transport.Atropine and maximum output pacing unsuccessful.Cpr initiated immediately pta.Pea on arrival to ed, intubated.Attempted to maintain heart rate and blood pressure with dopamine without benefit.Levo and epi drips initiated.Transcutaneous pacing completely ineffective.Transvenous pacemaker stabilized pt for tx to genesis.

• Brand Name: ZOLL ONE STEP CPR COMPLETE PADS
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 11731408
• MDR Text Key: 247682726
• Report Number: MW5100983
• Device Sequence Number: 1
• Product Code: MKJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

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
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 80