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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR
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ZOLL CIRCULATION AUTOPULSE RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR Back to Search Results
Model Number MODEL 100
Device Problem Complete Loss of Power (4015)
Patient Problem Insufficient Information (4580)
Event Date 12/09/2022
Event Type  malfunction  
Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
 
Event Description
During patient use, the autopulse platform (sn (b)(4) shuts off.Two autopulse li-ion batteries (sn (b)(4) and (b)(4) were used during the event.Patient's status information was requested but the customer did not provide a response.
 
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Brand Name
AUTOPULSE RESUSCITATION MODEL 100
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 Key16080950
MDR Text Key306521261
Report Number3010617000-2022-02111
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 12/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2022
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? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2016
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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