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

Model Number MODEL 100

Device Problems Component Missing (2306); Device Displays Incorrect Message (2591)

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

Event Date 06/18/2014

Event Type  malfunction  

Event Description

It was initially reported that during a shift check, the load plate screw of the autopulse platform was missing and the clutch was sticky.No patient involvement was reported.The autopulse platform was subsequently returned to zoll for investigation.The platform displayed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) message upon power up.Although the customer did not report this, ua 7 is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(6) 2014 for investigation.Investigation results as follows: visual inspection was performed and the reported issues of a load plate screw missing and a sticky clutch were confirmed.Inspection identified that the top cover was damaged, the front enclosure was cracked, the battery lock was bent and one of the load plate screws was missing.From the condition of the platform, the damages appear to have been due to wear and tear.Functional testing was performed and a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) message was observed upon power up of the platform.Further inspection identified the cause of the ua 7 to be a single point load cell that was not functioning properly.A review of the archive was performed and no issues were noted on the reported event date of (b)(6) 2014.Multiple ua 7 faults were observed on (b)(6) 2014 and are attributable to the load cell not functioning properly based on inspection results of the returned platform.Based on the investigation, the parts identified for replacement were the missing load plate screw, damaged clutch plate, single point load cell, top cover, front enclosure, battery compartment and battery lock.In summary, the reported complaint was confirmed during visual inspection and was found to be due to normal wear and tear.Following service, including replacement of the damaged parts, the device passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4014509
• MDR Text Key: 20973965
• Report Number: 3010617000-2014-00429
• Device Sequence Number: 1
• Product Code: DRM
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/10/2014

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2007
• 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