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

Model Number MODEL 100

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the display screen on the autopulse platform (serial #(b)(4)) blanked out and was no longer readable was not confirmed during initial functional test and archive data review.No device malfunction during functional testing.Autopulse platform performed as intended.No physical damage observed on the returned autopulse platform during visual inspection.However, contamination of unknown dried reddish liquid substance at the edge of the membrane keyboard but no liquid has penetrated inside the platform.The platform was cleaned to removed the contamination on the membrane keyboard.During archive data review, no discrepancy recorded.The autopulse passed the initial functional test without any fault or error, display is readable.The autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault error.Load cell characterization test passed.The autopulse platform passed all the functional tests.

Event Description

On (b)(6) 2020, based on new information from customer, the display screen on the autopulse platform (serial #(b)(4)) blanked out during the reanimation and was no longer readable.The compressions did continued normally.Patient's status information was requested but the customer did not provide a response, therefore patient's status is unknown.

• 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: 10590249
• MDR Text Key: 209441542
• Report Number: 3010617000-2020-01004
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000130
• UDI-Public: 00849111000130
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2020

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: 8700-0700-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• 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