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

Model Number MODEL 100

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the lcd of the autopulse platform (sn (b)(4) was blank, unreadable illuminated all leds and generated a clicking sound were confirmed during functional testing.The root cause of the reported complaint was due to a defective processor board (pca), likely due to a defective component.Upon visual inspection, no physical damage was observed on the autopulse platform.The platform's archive data could not be downloaded likely attributed to the defective processor board (pca).The platform failed the initialization (power-on-self-test) and the lcd displayed a blank screen, thus confirming the reported complaint.The processor board (pca) was replaced to remedy the fault.Following service, the autopulse platform passed 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.The autopulse platform lcd screen is functioning properly.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse platform with sn (b)(4).

Event Description

The customer reported that the lcd of the autopulse platform (sn (b)(4) was blank, unreadable and generated a clicking sound when powered on despite having a fully charged autopulse li-ion battery.The customer stated that the motor was moving freely and lifeband being in placed and free to move.Also, all the leds on the display panel are illuminated.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.

• Brand Name: AUTOPULSE 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: 14024555
• MDR Text Key: 288791155
• Report Number: 3010617000-2022-00350
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2022

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2020
• 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