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 INC AUTOPULSE® RESUSCITATION MODEL 100; 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 INC AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR Back to Search Results
Model Number MODEL 100
Device Problem Visual Prompts will not Clear (2281)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2024
Event Type  malfunction  
Manufacturer Narrative
During servicing of the autopulse platform (sn (b)(6)), the platform failed functional testing as it displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) upon powering up.The root cause of the (ua) 07 was due to a failure of single point load cell #1.The damaged enclosures and load cell failure were likely attributed to mishandling, such as a drop.During visual inspection, damaged front and bottom enclosures were observed.The observed physical damage appeared to be the characteristics of mishandling.The front and bottom enclosures were replaced to address the issue.The autopulse platform failed the initial functional testing due to the user advisory (ua) 07 error message displayed upon powering on.The load cell characterization test indicated load cell # 1 was over reporting.Single point load cell #1 was replaced to address the observed failure.Following service, the platform passed the load cell characterization check.The autopulse platform passed the run-in test without any fault or error.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse platform with sn (b)(6).
 
Event Description
During servicing of the autopulse platform (sn (b)(6)), the platform failed functional testing as it displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) upon powering up.No patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AUTOPULSE® RESUSCITATION MODEL 100
Type of Device
CARDIAC CHEST COMPRESSOR
Manufacturer (Section D)
ZOLL CIRCULATION INC
2000 ringwood ave
san jose CA 95131
Manufacturer (Section G)
ZOLL CIRCULATION INC
2000 ringwood ave
san jose CA 95131
Manufacturer Contact
kim thoa nguyen
2000 ringwood ave
san jose, CA 95131
4084192922
MDR Report Key18699622
MDR Text Key336432264
Report Number3010617000-2024-00125
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMODEL 100
Device Catalogue Number8700-0730-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-