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

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.

• 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 Key: 11099289
• MDR Text Key: 227070409
• Report Number: 3010617000-2020-01310
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• 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 Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1