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 AED3; 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 AED3; DEFIBRILLATOR Back to Search Results
Model Number AED3
Medical Device Problem Code Failure to Power Up (1476)
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 would not power up.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The complainant was contacted for return of the device.The customer has responded and indicated that the lithium battery was replaced and discarded.The device will not be returning to zoll at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AED3
Common Device Name
DEFIBRILLATOR
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key9129754
Report Number1220908-2019-02861
Device Sequence Number2312794
Product Code MKJ
UDI-Device Identifier00847946020941
UDI-Public00847946020941
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P160022
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) 09/06/2019
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 NumberAED3
Device Catalogue NumberAED3
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 09/06/2019
Supplement Date Received by Manufacturer09/06/2019
Initial Report FDA Received Date09/27/2019
Supplement Report FDA Received Date10/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-