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

Model Number MODEL 100

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the display of the autopulse platform (sn (b)(4) does not power on" was confirmed during initial functional testing.The root cause of the lcd failure was due to a defective processor board and load cell amp cable, likely attributed to normal wear and tear of the platform.The autopulse platform was manufactured in march 2008 and is more than 12 years old, past the expected service life of 5 years.Visual inspection was performed and unrelated to the reported complaint found a damaged front and bottom enclosures and bent battery lock, likely due to normal wear and tear or due to mishandling.The damaged parts were replaced to address the issue.The autopulse platform failed the initial functional test due to intermittent lcd failure, thus confirming the customer complaint.The defective processor board and load cell amp cable were replaced to address the reported issue.Following the service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with sn (b)(4).

Event Description

As reported, during the shift check, the lcd display of the autopulse platform (sn (b)(4) was blank.The platform was tested with a good known battery with no results.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: 10624229
• MDR Text Key: 209841811
• Report Number: 3010617000-2020-00968
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/03/2020

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• 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