MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the lcd screen of the autopulse platform (s/n (b)(4)) was "distorted" was confirmed during visual inspection.The autopulse platform was able to power up without any issues, and the lcd backlight turned on.However, the lcd screen was blurry, had visual noise, and was not readable.The root cause of the reported complaint was the defective lcd assembly, and it was replaced to remedy the fault.The defective lcd screen and cracked top cover were likely attributed to mishandling such as a drop.Visual inspection revealed that the top cover had a long crack, close to the lcd assembly, unrelated to the reported complaint.The observed physical damage appeared to be the characteristics of harsh impacts due to user mishandling.The top cover will be replaced to address the issue.The archive data review showed no significant discrepancies or errors.The autopulse platform passed the initial functional test without any fault or error.Also, the autopulse platform passed a functional test using lrtf (large resuscitation test fixture) with known-good batteries for 5 minutes.Upon service completion, the autopulse platform will be subjected to final functional test to ensure that the device will pass all testing criteria.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for autopulse platform with serial number (b)(4).

Event Description

The customer reported that the lcd screen of the autopulse platform (s/n (b)(4)) was "distorted".The customer did not provide any further information.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION MODEL 100
• 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: 13594728
• MDR Text Key: 286512270
• Report Number: 3010617000-2022-00172
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2022

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2021
• 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