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 Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "system error, out of service, revert to manual cpr" message on the autopulse platform (serial (b)(4)) was not confirmed during functional testing and during archive data review.Unrelated to the reported complaint, a damaged load plate cover of the autopulse platform was observed during visual inspection.This type of damaged on the autopulse platform was likely attributed due to normal wear and tear.The autopulse platform is a reusable device and was manufactured in december 2011.The device has been operating for over 7 years and has exceeded its expected serviceable life of 5 years.The damaged load plate cover was replaced.During archive data review, no significant discrepancies was observed.Initial functional testing of the autopulse platform was performed and it passed all functional tests and meets all required specifications.The autopulse platform is ready for clinical use.Historical complaints were reviewed for service information related to the reported complaint and there were two similar complaints reported for autopulse with serial number (b)(4).Ccr (b)(4), reported on (b)(6) 2013, reported complaint was resolved by using apvision3 software to clear the error and ccr (b)(4), reported on (b)(6) 2018, reported complaint was confirmed, the processor board was replaced to remedy the issue.

Event Description

During patient use, customer reported that the autopulse platform (serial (b)(4)) displayed "system error, out of service, revert to manual cpr " upon powering on.Error message could not be cleared by the user.No known impact or consequence to patient information was available.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC 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: kim nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 8363853
• MDR Text Key: 137421607
• Report Number: 3010617000-2019-00129
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• 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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1