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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 Device Inoperable (1663); Visual Prompts will not Clear (2281); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 04/27/2017
Event Type  Malfunction  
Manufacturer Narrative

The autopulse platform (b)(4) was returned for evaluation. The customer reported complaint for the platform displaying "system error, out of service, revert to manual cpr" was confirmed during functional testing. The root cause was found to be due to defective processor board. The processor board was replaced to remedy the fault. In previous service repair on (b)(6) 2017 the platform passed functional testing before being returned to customer and was unrelated to the reported complaint. Visual inspection of the returned platform was performed and no physical damage was noted. No discrepancies were found in the archive data. During the initial functional testing, the platform could not be powered on. After disconnecting and reconnecting the power switch, the platform work as intended. The platform has passed all the functional testing criteria.

 
Event Description

It was reported that during shift check, the autopulse platform (b)(4) was not powering up. The customer tried to use multiple li-ion batteries; however, the platform did not power on. The customer just received the platform from service. No other information was provided.

 
Manufacturer Narrative

The customer reported complaint was confirmed during the initial functional testing. The power switch cable was replaced in order to avoid the re-occurrence of the reported complaint. No physical damage was noted during visual inspection. No discrepancies were found in the archive data. The platform did not power on during the initial functional testing; however, after disconnecting and reconnecting the power switch cable, the platform worked as intended for use. Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for autopulse sn (b)(4).

 
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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 Key6584217
MDR Text Key75857901
Report Number3010617000-2017-00378
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/25/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/23/2017
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 Manufacturer05/05/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/05/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/26/2008
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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