Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 E SERIES DEFIBRILLATOR
  • 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 E SERIES DEFIBRILLATOR Back to Search Results
Model Number E SERIES
Medical Device Problem Code Failure to Power Up (1476)
Health Effect - Clinical Code No Information (3190)
Date of Event 02/16/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event or Problem Description
Complainant alleged that while attempting to treat a (b)(6) year old male patient, the device would intermittently not power up.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
 
Additional Manufacturer Narrative
The malfunction was duplicated and the system board was replaced to resolve the malfunction.Analysis of reports of this type has not identified an increase in trend.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
E SERIES DEFIBRILLATOR
Common Device Name
E SERIES
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key7338497
Report Number1220908-2018-00596
Device Sequence Number16433658
Product Code MKJ
UDI-Device Identifier00847946010218
UDI-Public00847946010218
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K042007
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/21/2018
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
Operator of Device Other
Device Model NumberE SERIES
Device Catalogue NumberE SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2018
Initial Date Received by Manufacturer 02/21/2018
Supplement Date Received by Manufacturer02/21/2018
Initial Report FDA Received Date03/14/2018
Supplement Report FDA Received Date04/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age60 YR
-
-