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 PROPAQ MD 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 PROPAQ MD DEFIBRILLATOR Back to Search Results
Model Number PROPAQ MD
Device Problem No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2014
Event Type  malfunction  
Event Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the devices display intermittently would blank out and clinical information could not be read.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
 
Manufacturer Narrative
Zoll medical corporation has receivd the product and will be providing a follow-up report when our investigation is completed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROPAQ MD DEFIBRILLATOR
Type of Device
PROPAQ MD
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
chelmsford MA
Manufacturer Contact
scott august
269 mill road
chelmsford, MA 01824-4105
9784219552
MDR Report Key4076906
MDR Text Key4850060
Report Number1220908-2014-02035
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Unknown
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPROPAQ MD
Device Catalogue NumberPROPAQ MD
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/06/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received07/30/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-