MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ONESTEP PEDIATRIC ELECTRODES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number 8900-000219-01

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2016

Event Type  malfunction  

Event Description

Infant brought to emergency in full arrest.Defibrillator pads were placed.When cpr was started, the pads were not communicating the depth and rate of compressions.Cpr was continued without changing the pads.He never had a shockable rhythm as he did respond to 3 doses of epinephrine.A ct showed concerns for congenital heart disease.He was admitted to the picu and cardiology was consulted.

• Brand Name: ONESTEP PEDIATRIC ELECTRODES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 & 271 mill road; chelmsford MA 01824
• MDR Report Key: 6043243
• MDR Text Key: 57932409
• Report Number: 6043243
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/21/2018
• Device Catalogue Number: 8900-000219-01
• Device Lot Number: 2116
• Other Device ID Number: (01)00847946023348(17)180521(
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS; DEFIBRILLATOR MONITOR WAS CHECKED AFTER THE EVENT
• Patient Weight: 3