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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

The customer complaint of platform did not start compressions was confirmed during review of the retrieved archive data and functional testing of the returned autopulse platform (sn (b)(4)).Following service, including replacement of the front enclosure, the platform passed all testing criteria.As part of routine service during testing, the platform was examined and found damaged front enclosure, unrelated to the reported complaint.Front enclosure was replaced to address the issue.Review of the retrieved archive data, found a system error message (a single event of latch error 71-motor drive train command issue) occurred on the reported event date.In addition, the archive data also showed ua2 (compression tracking error) and ua28 (loss of clutch connectivity) occurred on the reported event date, unrelated to the reported complaint.To remedy the system error (latch error 71), ap vision 3 software was used to clear this error.User advisory 2 is an indication that the autopulse has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.Initial functional testing could not be completed since the reported system error message (latch error 71) appeared upon powering on the platform.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).

Event Description

During patient use on patient in cardiac arrest, the autopulse platform (sn (b)(4)) was power up and patient was aligned, however, the platform did not start compressions.No error messages were reported.The crew replaced battery with no change.Manual cpr was immediately performed for an unspecified amount of time.No patient outcome was provided.No patient harm or consequence was reported.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• 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 thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7617428
• MDR Text Key: 111997305
• Report Number: 3010617000-2018-00641
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• 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: 05/29/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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