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

Model Number MODEL 100

Device Problems Crack (1135); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2014

Event Type  malfunction  

Event Description

It was initially reported that on (b)(6) 2014, the bottom lower housing of the autopulse platform has some cracks and a noise was coming from inside the platform, indicating that there is loose hardware inside the device.The platform is still functional.No patient involvement was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During investigation, the autopulse platform displayed a user advisory (ua) 27 (encoder fault (>3000 rpm)) message.Additionally, during review of the platform's archive data, it was observed that a user advisory 18 (max take-up revolutions exceeded) message occurred on the reported event date of (b)(6) 2014.Although the customer did not report this, ua 18 and 27 are considered reportable malfunctions.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 12/2/2014 for investigation.Investigation results as follows: visual inspection of the returned platform was performed and found that the front enclosure, motor cover and top cover were damaged.The platform underwent initial functional testing using an lrtf (large resuscitation test fixture, equivalent to a 250 pound patient) and within 30 seconds the platform displayed a user advisory (ua) 27 (encoder fault (>3000 rpm)) message.A review of the archive was performed which found that a ua18 (max take-up revolutions exceeded) occurred on the reported event date of (b)(6) 2014.Multiple ua 27's were also observed throughout the archive.The front enclosure, motor cover and top cover were replaced to remedy the reported complaint.Additional work performed to ensure that the autopulse platform is functioning without issue: lcd and load cell amp cable and the encoder gearbox were all replaced.The platform underwent and passed all final functional testing.The customer's reported complaint of the platform having cracks on the bottom of the housing and something being loose inside was confirmed through visual inspection of the returned platform.The encoder gearbox was replaced to remedy the user advisory 18 and 27 faults found in the archive.

• 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: 4382782
• MDR Text Key: 5260194
• Report Number: 3010617000-2015-00004
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• 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: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2007
• 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