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: COVIDIEN CADENCE ZOLL ADULT RTS; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
  • 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
 

COVIDIEN CADENCE ZOLL ADULT RTS; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) Back to Search Results
Model Number 22770R
Device Problems Electrical Shorting (2926); Incomplete or Inadequate Connection (4037)
Patient Problem No Patient Involvement (2645)
Event Date 03/04/2019
Event Type  malfunction  
Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
 
Event Description
The customer reported when the defib pads were plugged into the zoll, the machine shows "defib pad short".The message appeared immediately prior to patient involvement.The series number of the zoll machine is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CADENCE ZOLL ADULT RTS
Type of Device
PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
Manufacturer (Section D)
COVIDIEN
2 ludlow parkway
chicopee MA 01022
Manufacturer (Section G)
COVIDIEN
2 ludlow parkway
chicopee MA 01022
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key8444292
MDR Text Key139575766
Report Number1219103-2019-00229
Device Sequence Number1
Product Code DRO
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 03/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number22770R
Device Catalogue Number22770R
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/04/2019
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
-
-