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 Consequences Or Impact To Patient (2199)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(4)) displayed user advisory "(ua)12" (lifeband not detected) error message was not confirmed during functional testing but confirmed during archive data review.The returned autopulse platform passed the initial functional test without any fault or error.The returned autopulse platform performed as intended.The probable cause of the (ua)12 error was due to user error in which likely the lifeband was not properly installed or not fully inserted into the drive shaft during the deployment.Note that user advisory error messages are designed into the platform when one of several conditions is detected.Ua12 error message alerts the lifeband is not properly installed.This can be cleared by ensuring that the lifeband is properly installed and restarting the platform.No physical damage was observed on the returned autopulse platform during visual inspection.During archive data review, multiple ua12 (lifeband not detected) occurred around the reported event date, thus confirming the reported complaint.The returned autopulse platform passed the initial functional test without any fault or error.Performed the lifeband clip detect switch inspection.Verified the switch closes and the switch lever is parallel to the switch case, and the platform does not fault to user advisory 12.Also, inspected the two screws (holding the switch lever parallel to the switch case) are present and correctly tightened.The platform was re-evaluated through the run_in test using the 95% patient test fixture (lrtf) with good known test batteries until discharged without any fault or error.The autopulse has passed all the testing and meets all required specifications.

Event Description

During patient use, customer reported that the autopulse platform (serial #(b)(4)) displayed user advisory - "(ua)12" (lifeband not present).The crew were unable to clear the error message and performed manual cpr.No consequences or impact to patient.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10429541
• MDR Text Key: 203683293
• Report Number: 3010617000-2020-00801
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 08/19/2020

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2019
• 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