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

Model Number MODEL 100

Device Problems Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported issue of the lifeband not stay on platform was confirmed during the functional testing and in review of the archive data.Lifeband holding tabs on the motor cover and encoder cover are broken and require replacement.In addition, crack in the top cover was also confirmed and require replacement.Visual inspection showed damage to the battery box, and battery connection on power distribution board, unrelated to the reported complaint.The autopulse platform is a reusable device and was manufactured in 2009 and is over 8 years old, it has exceeded its expected service life of 5 years.Data archive showed failures for ua2 (compression tracking error) and ua17 (max motor on time exceeded during active operation) unrelated to the reported complaint.Load cell was replaced and cleaning and adjusting of rusty brake gap was performed to eliminate these errors.After upgrades and replacement of defective parts, the platform was further tested for 30 minutes and passed all functional testing criteria and met all required specifications.Historical complaints were reviewed for service information related to the reported complaint and there was no similar history of complaint reported for autopulse with serial number (b)(4).

Event Description

During patient use, the lifeband did not stay on (falls out) the board.Manual cpr was performed and patient care was not compromised.In addition, customer noted a crack on the bottom of the autopulse platform, near the lifeband area.No further 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 7187819
• MDR Text Key: 97583167
• Report Number: 3010617000-2018-00105
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/12/2018

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: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2009
• 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