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 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of lcd on the autoupulse platform (serial# (b)(4)) was very dim and display was unable to read the text contents was confirmed during functional testing.Missing line on the lcd screen was observed during power on of the autopulse platform.The root cause of the reported lcd issue was due to a defective lcd, likely attributed to a defective component.The lcd was replaced to remedy this issue.During visual inspection, unrelated to the reported complaint, a cracked front enclosure and a bent battery lock were observed on the autopulse platform.These physical damages are likely due to user mishandling, such as a drop.The front enclosure and battery lock were replaced to address these issues.The autopulse platform passed the initial functional testing.Further functional testing, unrelated to the reported complaint, observed intermittently depleted battery indicator on the autopulse platform's lcd screen.The archive data was reviewed and showed multiple user advisory (ua)03 (error communicating with battery controller).As a precautionary measure, the power distribution board (pdb) was replaced to remedy this issue.After service repair completion, 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 or error.The ap platform passed all functional tests.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).

Event Description

Customer reported that the lcd on the autoupulse platform (serial# (b)(4)) was very dim and display was unable to read the text contents.Patient use information was requested but no additional information was provided, therefore patient use 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: 11015731
• MDR Text Key: 226650894
• Report Number: 3010617000-2020-01257
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: 12/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• 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