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U.S. Department of Health and Human Services

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

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ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR Back to Search Results
Model Number MODEL 100
Device Problem Visual Prompts will not Clear (2281)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2020
Event Type  malfunction  
Manufacturer Narrative
The autopulse platform in complaint was returned to zoll on (b)(6) 2020 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
 
Event Description
During shift check, the autopulse platform (sn: (b)(4)) displayed user advisory (ua)18 (max take-up revolution exceeded) error message.No troubleshooting was performed.No patient involvement.
 
Manufacturer Narrative
The reported complaint of "the autopulse platform (sn: (b)(6)) displayed user advisory (ua)18 (max take-up revolution exceeded) error message" was confirmed based on the archive data review but was not confirmed during functional testing.No device malfunction was observed that could have caused or contributed to the reported ua18 error message.The probable root cause of the ua18 error was that the autopulse detected no weight present on the platform.During the visual inspection, the front enclosure was observed to be chipped and damaged with broken screw fittings.In addition, the battery lock was observed to be bent.The physical damages were unrelated to the reported complaint, likely attributed to normal wear and tear and/or due to user mishandling.The returned platform was manufactured at the end of december 2015, and it is 5 years old and has reached its expected service life of 5 years.The front enclosure and the battery lock will be replaced to address the issues.The archive data review showed multiple ua18 (max take-up revolution exceeded) error messages to have occurred around the customer's reported event date; thus, confirming the reported complaint.User advisory is a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the battery hangtag - advisory codes description and action, user advisory 18 occurs when the driveshaft has traveled past the maximum number of revolutions without detecting a patient/object.As take-up is performed, the driveshaft moves the lifeband past the maximum allowable take-up depth without detecting a patient/object, which results in a load change at the load plate.The take-up position is achieved when the load plates sense an additional 6 lbs.Of load compared to the pre-take-up load.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient/object and the band are properly aligned, and press restart.The autopulse platform passed the initial functional test without any fault or error, unable to replicate the customer's reported complaint.Awaiting the customer's approval for repair.
 
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Brand Name
AUTOPULSE PLATFORM RESUSCITATION
Type of Device
CARDIAC CHEST COMPRESSOR
Manufacturer (Section D)
ZOLL CIRCULATION
2000 ringwood ave.
san jose CA 95131
MDR Report Key11099289
MDR Text Key227070409
Report Number3010617000-2020-01310
Device Sequence Number1
Product Code DRM
UDI-Device Identifier00849111000512
UDI-Public00849111000512
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,health
Type of Report Initial,Followup
Report Date 01/11/2021
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 Number8700-0730-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2020
Initial Date Manufacturer Received 12/09/2020
Initial Date FDA Received12/30/2020
Supplement Dates Manufacturer Received01/05/2021
Supplement Dates FDA Received01/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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