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
Device Problem Unexpected Shutdown (4019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device inappropriately shut down.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
 
Manufacturer Narrative
The device was returned to zoll medical canada for evaluation.The customer's report was attributed to water ingress.Our evaluation found internal water damage.Due to the observed condition of the device, the device was deemed compromised and cannot be repaired.The device was labeled "not for clinical use" 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
X SERIES
Type of Device
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key11042708
MDR Text Key222699235
Report Number1220908-2020-04046
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K112432/P160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberX SERIES
Device Catalogue NumberX SERIES
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-