• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZOLL CIRCULATION AUTOPULSE RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR Back to Search Results
Model Number MODEL 100
Device Problem Visual Prompts will not Clear (2281)
Patient Problem Insufficient Information (4580)
Event Date 12/10/2020
Event Type  malfunction  
Manufacturer Narrative
The device associated with this complaint has been received, however, the investigation is pending.A follow-up report will be filed when the investigation has been completed.
 
Event Description
The customer reported that the autopulse platform (sn (b)(4)) displayed "system error, out of service, revert to manual cpr" error message.Patient use information was requested but no additional information was provided, therefore patient use is unknown.
 
Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(6) displayed "system error, out of service, revert to manual cpr" error message was confirmed during the functional testing and based on the archive data review.The root cause for the system error was due to the defective processor board, as a result of normal wear and tear of the platform.The autopulse platform is a reusable device and was manufactured in february 2008 and is more than 12 years old, well beyond the expected service life of 5 years.There was no physical damage observed on the returned autopulse platform during visual inspection.The data in the archive was partially recoverable, however, it revealed latch error 136 - internal parameter corrupted, thus confirming the customer complaint.The defective processor was replaced to remedy the system error.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering on.After the processor board was replaced, the platform was further tested and failed with user advisory (ua) 02 (compression tracking error) message, unrelated to the reported complaint.The defective load cell was replaced to remedy the fault.The defective load cell was likely attributed to mishandling such as a drop or a defective component.After the service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial number (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AUTOPULSE RESUSCITATION MODEL 100
Type of Device
CARDIAC CHEST COMPRESSOR
Manufacturer (Section D)
ZOLL CIRCULATION
2000 ringwood ave.
san jose CA 95131
MDR Report Key11093766
MDR Text Key227070316
Report Number3010617000-2020-01327
Device Sequence Number1
Product Code DRM
UDI-Device Identifier00849111000277
UDI-Public00849111000277
Combination Product (y/n)N
PMA/PMN Number
K112998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMODEL 100
Device Catalogue Number8700-0700-01-66
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2020
Initial Date Manufacturer Received 12/10/2020
Initial Date FDA Received12/30/2020
Supplement Dates Manufacturer Received12/30/2020
Supplement Dates FDA Received01/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-