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

Model Number MODEL 100

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 12/15/2019

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) with a blank screen was confirmed during functional testing, the root cause was due to a defective lcd board like due to user mishandling.Upon visual inspection, the top cover and front enclosure were damaged and the clutch plate was observed to be sticky.These observations are not related to the reported event.Evaluation of the platform, the user control panel displayed a blank screen due to a defective lcd board.Upon customer approval, the top cover, front enclosure and processor board will be replaced and the device will be further tested to full specification.Historical records were reviewed for service information related to the reported complaint and there was no history of complaint reported for autopulse with serial number (b)(4).

Event Description

During shift check, the autopulse platform (sn (b)(4)) was observed with a blank user control panel.The user was unable to resolve the issue with multiple autopulse li-ion batteries.No patient involvement.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• 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: 9578678
• MDR Text Key: 181479660
• Report Number: 3010617000-2020-00009
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• 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: 12/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2015
• 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