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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 Problems Failure to Power Up (1476); Device Inoperable (1663); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2017
Event Type  Malfunction  
Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) not being able to power on with a newly charged battery was unable to be reproduced during functional evaluation of the platform and could not be confirmed upon review of the retrieved archive data. Review of the archive data retrieved from the autopulse platform (sn (b)(4)) revealed that the platform was not in use on (b)(6) 2017. The events recorded on (b)(6) 2017 contained a "battery lost" message caused by the platform losing connection with the battery and powering off. Following this, the platform was powered back on and displayed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error message that was subsequently cleared by the user. The ua 7 error message was attributed to the patient not properly oriented on the platform and was unrelated to the reported event. There were no device deficiencies found during evaluation of the platform which could have caused or contributed to the reported event. The platform was tested including the load characterization and confirmed that both cell modules are functioning within specification. As part of routine service during testing, the platform was examined and found physical damages including a stiff driveshaft. These observations were unrelated to the reported event. After the damaged parts were replaced and the clutch plate was deburred, the platform was further tested and passed all functional testing criteria and met all required specifications without any observed issue. The autopulse platform is a reusable device and was manufactured on 13 july 2005 and has exceeded its expected service life of 5 years. Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).

 
Event Description

It was reported that the autopulse platform (sn (b)(4)) using a newly charged autopulse battery did not power on during patient use. Replacing to another battery did not resolve the issue. There was no known patient impact or consequence. No further information was provided.

 
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Brand NameAUTOPULSE® RESUSCITATION MODEL 100
Type of DeviceCARDIAC 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
joy patel
2000 ringwood ave,
san jose, CA 95131
4084192957
MDR Report Key6659173
MDR Text Key78155703
Report Number3010617000-2017-00391
Device Sequence Number1
Product Code DRM
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK112998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 06/21/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMODEL 100
Device Catalogue Number8700-0700-01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/31/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/13/2005
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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