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 X SERIES; DEFIBRILLATOR/PACEMAKER
  • 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 X SERIES; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number X SERIES
Medical Device Problem Codes Loss of Power (1475); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The reported malfunctions of "shut down" was observed and attributed to a loose battery socket contact pin.The reported malfunction of "unknown fault" was not replicated or confirmed.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
Event or Problem Description
Complainant alleged that during functional testing, the device inappropriately shut down and displayed an "invalid fault code" error message.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
X SERIES
Common Device Name
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key7488614
Report Number1220908-2018-01307
Device Sequence Number19274706
Product Code MKJ
UDI-Device Identifier00847946005917
UDI-Public00847946005917
Combination Product (Y/N)N
Initial Reporter StateWV
Initial Reporter CountryUS
PMA/510(K) Number
K112432/P160
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/24/2018
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 NumberX SERIES
Device Catalogue NumberX SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/24/2018
Initial Report FDA Received Date05/04/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-