• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZOLL MEDICAL CORPORATION ONESTEP CPR PADS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number R2048-01
Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)
Event Date 09/07/2023
Event Type  malfunction  
Event Description
Patient required cardiopulmonary resuscitation (cpr) for pulseless electrical activity (pea) arrest.Gel of the front & back pads of the onestep rolled significantly.Pads were retained and zoll will be contacted to return pads.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ONESTEP CPR PADS
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
525 narragansett park dr
pawtucket RI 02861
MDR Report Key18551873
MDR Text Key333352345
Report Number18551873
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberR2048-01
Device Catalogue NumberR2048-01
Device Lot Number1023H
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/08/2023
Event Location Hospital
Date Report to Manufacturer01/22/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/22/2024
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-