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

Model Number MODEL 100

Device Problems Loose or Intermittent Connection (1371); Unintended Collision (1429); Device Inoperable (1663); Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/03/2014

Event Type  malfunction  

Event Description

Complainant alleged that the autopulse® platform stopped after being bumped.This resulted in some screws on the back of the platform, in the area where the lifeband is installed becoming loose.Therefore, it was not possible to bring this platform on a patient call.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned for evaluation.Visual inspection was performed and found that the battery lock was missing.The load plate screws were found to be loose and needed to be re-torqued, thus confirming the reported complaint.Functional testing was performed with a large resuscitation test fixture (equivalent to a 250 pound patient) for approximately 10 minutes followed by a user advisory 27 (encoder fault, > 3000 rpm) being displayed.Further inspection was performed and the cause of the ua 27 was determined to be that the encoder gearbox was not functioning properly.A review of the archive was performed and multiple user advisory (ua) 27 (encoder fault, > 3000 rpm), user advisory (ua) 45 (not at "home" position after power-on/re-start), and user advisory (ua) 12 (lifeband not present) codes were observed on the reported event date of (b)(6) 2014.Based on evaluation of the device, the ua 27 codes are attributed to the encoder gearbox not functioning properly.The ua 45 codes were likely due to the lifeband straps not being pulled completely out prior to turning the device on.The ua 12 codes are due to the lifeband belt clip not being detected in the platform spool shaft.Based on the investigation, the part identified for replacement was the missing battery lock.The load plate screws were also re-torqued to remedy the complaint.In summary, the reported complaint was confirmed based on visual inspection as well as archive review.Visual inspection confirmed that the load plate screws were loose and needed to be re-torqued.The archive data also showed that multiple ua codes occurred on the reported event date, leading to the platform stopping operation.Based on evaluation of the device, the ua 27 codes are attributed to the encoder gearbox not functioning properly.The ua 45 codes were likely due to the lifeband straps not being pulled completely out prior to turning the device on.The ua 12 codes are due to the lifeband belt clip not being detected in the platform spool shaft.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4221952
• MDR Text Key: 17292146
• Report Number: 3010617000-2014-00589
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• 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: 8700-0740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2008
• 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