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 CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR
  • 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 CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR Back to Search Results
Model Number MODEL 100
Medical Device Problem Code Visual Prompts will not Clear (2281)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/24/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The autopulse platform (sn (b)(4)) in complaint has not yet received the product for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
 
Event or Problem Description
During shift check, the autopulse platform (sn (b)(4)) displayed fault code 16 (timeout moving to take-up position) error message.The platform did not perform compression.No patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AUTOPULSE PLATFORM RESUSCITATION
Common Device Name
CARDIAC CHEST COMPRESSOR
Manufacturer (Section D)
ZOLL CIRCULATION
2000 ringwood ave.
san jose, ca
MDR Report Key10281429
Report Number3010617000-2020-00722
Device Sequence Number689685
Product Code DRM
UDI-Device Identifier00849111001212
UDI-Public00849111001212
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
K112998
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/15/2020
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 Health Professional
Device Model NumberMODEL 100
Device Catalogue Number8700-0740-04
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/24/2020
Initial Report FDA Received Date07/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-