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

Model Number MODEL 100

Device Problems Retraction Problem (1536); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2015

Event Type  malfunction  

Event Description

It was reported that the autopulse platform displayed a user advisory 16 (timeout moving to take-up position) message during a demo.The customer also reported that the lifeband was unable to retract.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Manufacturer Narrative

The autopulse platform was returned to the manufacturer for evaluation on 07/15/2015.Visual inspection was performed and no physical damages were observed.Functional testing was performed and the reported complaint was confirmed; the platform displayed a user advisory 16 (time out moving to take-up position) upon power up.Further inspection of the device identified the cause of the ua 16 to be that the drive train motor brake rusted and seized up.The silicon sealant of the drive train motor was observed to have popped loose, which allowed fluid ingress to get into the motor.Upon cleaning the corrosion and rust off, a brake gap inspection was performed and it was verified that the brake gap was within specification of 0.008"+ or - 0.001".Functional testing was then continued using a large resuscitation test fixture for several hours and no other user advisories or warnings were exhibited.Please note that the observed user advisory (ua) 16 message will not allow the lifeband to retract, therefore the device was performing as intended.A review of the archive was performed and no user advisory (ua) 16 messages were observed on the reported event date of (b)(6) 2015.User advisory (ua) 16 messages however, were observed on (b)(6) 2015, thus confirming the customer's reported complaint.Based on the investigation, the parts identified for replacement were the drivetrain motor.In summary, the reported complaint of the platform displaying a ua 16 code was confirmed during functional testing as well as archive review.The cause was confirmed to be that the drivetrain had rusted and seized up.The drivetrain was replaced to remedy the complaint.After replacement of the part identified during investigation, the platform passed all final functional testing.

• 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: 4876525
• MDR Text Key: 6261564
• Report Number: 3010617000-2015-00379
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: CE
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• 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: 07/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2014
• 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