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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event was confirmed through functional testing and archive data review of the autopulse platform (sn (b)(4)).The root cause is due to a defective load cell.Upon visual inspection no physical damage was observed.Evaluation of the platform during initial power up, revealed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error message on the user control panel.The archive data was reviewed and contained multiple ua 7 error message on the reported event.A load characterization check was performed and identified a defective load cell.After replacement of the load cell, the platform was further functionally tested to full specification and operated as intended with no further issues observed.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for the autopulse platform with serial number (b)(4).

Event Description

During deployment, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 7 error message upon power up.User tried to troubleshoot but was unable to clear the ua 7 error message.The crew immediately performed manual cpr.No known impact or consequence to patient 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: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7644295
• MDR Text Key: 112567966
• Report Number: 3010617000-2018-00681
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• 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: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2017
• 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