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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 Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2023
Event Type  malfunction  
Manufacturer Narrative
During device evaluation and servicing of the autopulse platform (sn (b)(6), the platform failed initial functional testing due to a damaged integrated encoder gearbox and shaft lock plunger.Internal functional inspection revealed that the drivetrain motor was not disengaging, causing constant pressure on the clutch and integrated encoder gearbox.This damaged multiple components, including the integrated encoder gearbox, shaft lock plunger, monolithic plunger, belt clip retainer, and a stuck clutch.All the damaged parts were replaced to resolve the noted issues.The customer's initial request was to have the autopulse platform serviced for a broken clip connecting to the lifeband.This was verified during a visual-functional inspection.The slot on the bottom cover of the platform, to which the lifeband cover plate locking tab gets snapped, was observed to be broken.This did not affect the functionality of the autopulse platform.Further visual inspection revealed several more physical damages, unrelated to the noted failed functional testing.Based on the photos provided by the zoll service team, a vertical crack was going through one of the screw fittings of the front enclosure.One of the head restraint wires was cut in the middle, but it did not render the autopulse platform non-functional.All the observed physical damages were attributed to user mishandling.The top cover, front, and bottom enclosures have been replaced at zoll several times.They were replaced again to address the observed physical damages.Following service, a brake gap inspection was performed and verified the brake gap was within the specification.The autopulse platform was subjected to a final run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for the autopulse platform with serial number (b)(6).
 
Event Description
During device evaluation and servicing of the autopulse platform (sn (b)(6), the platform failed initial functional testing due to a damaged integrated encoder gearbox and shaft lock plunger.No patient involvement.
 
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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 Key18280084
MDR Text Key329918632
Report Number3010617000-2023-01026
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 12/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2023
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 Manufacturer12/01/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2018
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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