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

Model Number MODEL 100

Device Problems Break (1069); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2014

Event Type  malfunction  

Event Description

Complainant alleged that during a device check by the customer, it was observed that the top cover of the autopulse was broken and the platform did not work properly.Zoll (b)(4) confirmed that the top cover was broken and that there was a problem with the motor brake, as the platform displayed a user advisory (ua) 17 (max motor on time exceeded during active operation) message.No patient involvement was reported.No further information.

Manufacturer Narrative

Zoll (b)(4) received the product in complaint on 10/04/2014 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for analysis.Visual inspection of the returned platform shows that both patient head restraints and top cover were cracked.The lcd backlight was also observed to be flickering.The physical damages found during visual inspection are not related to the reported complaint that the platform did not work properly.The visual inspection however, confirmed the reported complaint that the top cover was broken.The damages appear to have been caused by normal wear and tear (autopulse manufactured in 9/2007).A review of the autopulse archive was performed and the reported complaint was confirmed.The archive data shows that a user advisory 17 (max motor on time exceeded during active operation) fault occurred on the reported event date.Other user advisories (uas) such as 18 (max take-up revolutions exceeded), 45 (not at "home" position after power-on/restart), and 19 (max applied load exceeded) also occurred on the reported event date.However, these user advisories are not related to the reported complaint.Functional testing was performed and the reported complaint was confirmed.After a few minutes, the platform stopped compressions and displayed a ua17 fault.It was observed that the drive train motor brake gap was too large and out of specification.The brake gap could not be adjusted back to specification, as the set screws would not lock into the encoder dimple locking hole, causing the brake to disengage.Based on the investigation, the parts identified for replacement were the top cover, lcd, both patient head restraint brackets and drive train short motor.In summary, the reported complaint that the platform did not work properly was confirmed during functional testing.The fault was found to be due to the defective drive train short motor causing the ua17 fault.The physical damages found during visual inspection confirmed the reported complaint that the top cover was broken.The ua18, ua19, and ua45 faults observed during the archive review are unrelated to the reported complaint.The root cause for these user advisories could not be determined.However, per the autopulse maintenance guide (p/n 11653-001), ua18 is an indication that there is no patient on the platform.The root cause for the ua45 could not be determined.However, per the autopulse® resuscitation system model 100 user guide (pn: 12555-001), if the driveshaft is not at its home position when the autopulse is powered on, a user advisory 45 will occur.This user advisory will persist until the driveshaft is returned to its home position.Upon replacement of all parts, the platform was re-evaluated through functional testing and the platform passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4191109
• MDR Text Key: 16083470
• Report Number: 3010617000-2014-00536
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2014

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2014
• Initial Date FDA Received: 10/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2007
• 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