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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR
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ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR Back to Search Results
Model Number MODEL 100
Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
Zoll has not received the autopulse platform (sn (b)(4)) for investigation.A follow-up report will be submitted when the product is returned and the investigation has been completed.
 
Event Description
During shift check, the autopulse platform (sn (b)(4)) showed a pixelated lcd black screen upon powering up.No patient involvement.
 
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Brand Name
AUTOPULSE PLATFORM RESUSCITATION
Type of Device
CARDIAC CHEST COMPRESSOR
Manufacturer (Section D)
ZOLL CIRCULATION
2000 ringwood ave.
san jose CA 95131
Manufacturer (Section G)
ZOLL CIRCULATION
2000 ringwood ave.
san jose CA 95131
Manufacturer Contact
kim thoa nguyen
2000 ringwood ave,
san jose, CA 95131
4084192922
MDR Report Key11085015
MDR Text Key227068733
Report Number3010617000-2020-01304
Device Sequence Number1
Product Code DRM
UDI-Device Identifier00849111001014
UDI-Public00849111001014
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K112998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMODEL 100
Device Catalogue Number8700-0740-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/27/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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