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

Model Number MODEL 100

Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was confirmed during evaluation of the returned autopulse platform ((b)(4)).The platform did not power on during initial functional testing.The root cause was determined to be a defective system processor board.As part of routine service during testing the device was further examined and found damaged front enclosure.To remedy the issue, the front enclosure was replaced.The autopulse platform is a reusable device and was manufactured in 2014.Therefore, this type of physical damage found during visual inspection is characteristic of normal wear and tear for the life of the device.Following the repair, the platform was further tested for 15 minutes with large resuscitation testing fixture, (lrtf) equivalent to 250 pound patient and passed all functional testing criteria and met all required specifications.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

As reported during shift check, the autopulse did not power on.Customer stated that they replaced and inserted another battery however, the issue was not resolved.No patient involvement on this event.

• 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 7499509
• MDR Text Key: 107877830
• Report Number: 3010617000-2018-00538
• 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: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• 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: 04/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2014
• 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