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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint for the platform displaying an error message user advisory (ua) 08 (motor controller fault detected) was confirmed during archive review and initial functional testing.Defective drive train motor was replaced to remedy the fault.Additionally, customer noted user advisory (ua) 45 (not at "home" position after power -on/restart) and user advisory (ua) 17 (max motor on time exceeded during active operation) errors were confirmed during archive review.However, these errors were cleared by the user.The platform failed the initial functional testing due to user advisory (ua) 08 error message displayed when the platform was powered on.Review of the archive data indicated (ua) 08, (ua) 02 and (ua) 18 errors occurred on the reported event date.However, (ua) 18 and (ua) 02 are unrelated to the reported complaint.The (ua) 02 (compression tracking error) and (ua) 18 (max take-up revolution exceeded) are clearable error messages and are designed into the platform to alert the operator that autopulse has detected one of several conditions.(ua) 02 is an indication that the autopulse has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.(ua) 18 is an indication that the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.Visual inspection was performed and found damaged front enclosure, bent battery lock pin and missing both load plate screws, unrelated to the reported complaint.Front enclosure, battery lock and missing load plate screws were replaced to address the issue.The autopulse platform is a reusable device and was manufactured in 2014.Therefore, this type of physical damage found during visual inspection is characteristic of normal wear and tear for the life of the device.After replacing the defective parts, the platform was further tested for 15 minutes with large resuscitation testing fixture, (lrtf) equivalent to 250 pound patient 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 previous history of complaints reported for autopulse platform sn (b)(4).

Event Description

During a shift check, the autopulse platform ((b)(4)) displayed the user advisory (ua) 45 (not at "home" position after power-on/restart) and (ua) 17 (max motor on time exceeded).Customer was able to clear these errors, however, platform displaying error message user advisory (ua) 08 (motor controller fault detected) after restart.Customer was unable to clear the error.No patient involvement was reported.

• 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: 7597971
• MDR Text Key: 111007525
• Report Number: 3010617000-2018-00630
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/13/2018

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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