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 06/02/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was confirmed during the device initial functional testing.The autopulse platform stopped compression due to multiple error messages ua 7 (discrepancy between load 1 and load 2 too large) verified in the archive data.The load sensing system has detected a weight/load imbalance between the two load cells.It was determined that the probable cause of the reported issue was due to over-reported (defective) on both load cell modules.Review of the archive data verified the reported (ua) 7 (discrepancy between load 1 and load 2 too large) error message, and initial functional testing of the autopulse platform could not be performed due to error message prompted on the screen.Unrelated to the reported complaint, during visual inspection, cracked front and bottom covers were observed, this types of physical damages on the device can occur due to normal wear and tear.The autopulse platform is a reusable device and was first manufactured on 01 oct 2010.The device has been operating for nearly 8 years and has exceeded its expected serviceable life of 5 years.After the removal of both front and bottom covers, wide corrosion and fluid damaged to the metalized inner surface of the autopulse blue (top) cover were observed.The blue top and bottom covers were replaced and as required, the unit was also bio-cleaned.Historical complaints were reviewed for service information relating to the reported complaint.As a result, there was no previous history of complaints reported for autopulse platform serial number (b)(4).

Event Description

As reported, during patient use, the autopulse platform (b)(4) stopped compressing and then prompted a user advisory error message ua 7 (discrepancy between load 1 and load 2 too large).The users tried adjusting the imbalance patient on the device but were unsuccessful clearing the ua 7 error message.Patient care was not compromised from the device's issue.Hence, no known impact or consequence to patient.

• 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: 7652989
• MDR Text Key: 112861112
• Report Number: 3010617000-2018-00684
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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: 06/11/2018
• 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: 10/03/2010
• 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