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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR
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ZOLL CIRCULATION INC AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR Back to Search Results
Model Number MODEL 100
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2024
Event Type  malfunction  
Manufacturer Narrative
During the preventative maintenance (pm) on (b)(6) 2024, zoll service personnel could not perform the functional testing of the returned autopulse platform (b)(6) due to the sticky drive shaft rotation.The platform's driveshaft was not rotating smoothly, exhibiting binding and resistance due to having a sticky clutch plate, likely attributed to the device's aging.The clutch plate was replaced to address the sticky shaft problem.The autopulse platform was manufactured in 2017 and is 7 years old, past the expected serviceable life of 5 years.Upon visual inspection, the battery box screw receiver was observed to be damaged.The physical damage appeared to be the characteristic of user mishandling.The screw receptacles in the battery box were repaired with putty to remedy the damage.Following service, the autopulse platform passed the final run-in test without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for autopulse platform with (b)(6).
 
Event Description
During the preventative maintenance (pm) on (b)(6) 2024, zoll service personnel could not perform the functional testing of the returned autopulse platform (b)(6) due to the sticky drive shaft rotation.No patient involvement.
 
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Brand Name
AUTOPULSE® RESUSCITATION MODEL 100
Type of Device
CARDIAC CHEST COMPRESSOR
Manufacturer (Section D)
ZOLL CIRCULATION INC
2000 ringwood ave
san jose CA
Manufacturer (Section G)
ZOLL CIRCULATION INC
2000 ringwood ave
san jose CA 95131
Manufacturer Contact
kimthoa sackrison
2000 ringwood ave
san jose, CA 95131
4084192922
MDR Report Key18975562
MDR Text Key338574531
Report Number3010617000-2024-00313
Device Sequence Number1
Product Code DRM
UDI-Device Identifier00849111065009
UDI-Public00849111065009
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMODEL 100
Device Catalogue Number8700-0700-03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2017
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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