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 No Display/Image (1183)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event or Problem Description
Complainant alleged that during functional testing, the device's display was not legible.Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The device was returned to zoll medical corporation for evaluation.During the investigation of the device to determine root cause, the technician observed physical damage consistent with mis-handling.The device was recertified and returned to the customer.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 Key6503185
Report Number1220908-2017-00870
Device Sequence Number14092
Product Code MKJ
UDI-Device Identifier00847946009168
UDI-Public00847946009168
Combination Product (Y/N)N
Initial Reporter StateNM
Initial Reporter CountryUS
PMA/510(K) Number
K042007
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 03/30/2017
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 Manufacturer04/21/2017
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer 03/30/2017
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date04/19/2017
Supplement Report FDA Received Date05/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-