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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the autopulse platform (sn (b)(4)) confirmed the customer reported event of damaged wire restraint loop.Additional issues were observed during visual inspection were damaged top cover, bottom cover, frayed wire on the fan assembly, missing battery latch and load plate screw; which are not related to the reported event.The autopulse platform is a reusable device and was manufactured on feb 21, 2008 and has exceeded its service life of 5 years old.This type of physical damage found during visual inspection is characteristic of normal wear and tear for the life of the device.As part of routine service during testing, the platform was evaluated.Upon initial functional testing, the platform displayed a user advisory (ua) 17 (motor on for too long during active operation) error message.The ua 17 error message was due to a defective drivetrain and motor controller board.Additionally, a load characterization check was performed and identified a defective load cell.Upon customer's approval, replacement of the top cover, bottom cover, cable, battery latch, load plate screw, load cell, drivetrain and motor controller board, the platform will be further tested.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse serial number (b)(4).

Event Description

It was initially reported by the customer that the autopulse platform (sn (b)(4)) wire restraint loop was damaged.The autopulse platform was returned to zoll for investigation.During initial functional testing, the platform displayed a user advisory 17 (motor on for too long during active operation) error message.

• 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 nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 8196522
• MDR Text Key: 131589260
• Report Number: 3010617000-2018-01273
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/26/2018

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: 12/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2008
• 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