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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Operational Issue (2914)

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

Event Date 01/05/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform (sn: (b)(4)) stopped compression was confirmed during review of archive data and functional testing.Review of the retrieved archive data, found multiple user advisory (ua) 2 (compression tracking error) messages on (b)(6) 2017 (not on the reported event date of (b)(6) 2018).During a run-in test, the ua2 appeared in the first 15 minutes of the test.Further evaluation found the root cause of the ua2 issue was due to a faulty load cell module 1.The autopulse platform is a reusable device and was manufactured in 2009 and has exceeded its expected service life of 5 years.Upon customer approval, the components will be replaced and the device will be further tested to full specification.Unrelated to the reported complaint, during visual inspection, the front cover was found cracked and the encoder drive shaft exhibited binding and resistance.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, the autopulse platform (sn: (b)(4)) stopped compression following an unknown user advisory message.The platform did not continue with compressions even after it was powered back on.The responding team immediately reverted to manual cpr.According to the reporter, the patient's outcome is not known.There is no known patient consequence 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: 7226500
• MDR Text Key: 98992342
• Report Number: 3010617000-2018-00083
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2018

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2009
• 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