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

Model Number MODEL 100

Device Problems Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the autopulse platform on (b)(6) 2019 for investigation; however, device investigation is still pending.A supplemental report will be filed when the investigation has been completed.

Event Description

During shift check, the autopulse platform was powered on for 20 seconds, and the lcd was observed blank.Then, the green and orange lights kept blinking.The fan could be heard running; however, the platform turned off by itself.The customer swapped out the batteries to attempt to resolve the issue; however, the issue was not resolved.No patient involvement.

Manufacturer Narrative

The reported event of "screen is blank and then the green and orange light keep blinking" and "unit turns off by itself" was not confirmed based on archive data and during functional testing.Device functions as intended.Visual inspection of the returned platform showed that the button pad (ui membrane switch assembly) was lifted in the lower right corner, which allows moisture entering the electronic components of the platform.Also, damage was observed to the top, bottom, front covers, and battery lock, unrelated to the reported complaint.The autopulse platform is a reusable device and was manufactured in april 2010 and has exceeded its expected service life of 5 years.The damage found is characteristic of normal wear and tear for the life of the device.A review of the autopulse platform archive was performed, and no significant discrepancies were observed.The autopulse platform passed the functional testing.Multiple restarts show no problems with the device.Following service, including replacement of all the damaged parts, the platform passed all testing criteria.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 9211222
• MDR Text Key: 164105164
• Report Number: 3010617000-2019-00927
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• 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: 10/02/2019
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1