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

Model Number MODEL 100

Device Problems Material Separation (1562); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 09/22/2014

Event Type  malfunction  

Event Description

It was initially reported that on (b)(6) 2014, the bottom lower housing of the autopulse platform was coming apart.Customer indicated that the platform worked fine.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.Although the customer did not report this, ua 27 is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 09/03/2014 for investigation.Investigation results as follows: visual inspection of the returned platform shows that the battery lock clip was bent and the bottom enclosure was cracked.It was also observed that the top cover and the front enclosure were damaged.The physical damages found during visual inspection confirmed the initial reported event of the bottom lower housing coming apart.The damages appear to have been caused by normal wear and tear (autopulse manufactured in september of 2008).A review of the autopulse platform's archive was performed and the archive data shows that no clinical use with a patient occurred on the initial reported event date of(b)(6) 2014.Functional testing was performed and the platform failed the initial testing.The platform ran with a large resuscitation test fixture (lrtf) and a user advisory (ua) 27 (encoder fault (>3000 rpm)) message was observed during testing.It was found that the integrated encoder gearbox was at fault.Based on the initial investigation, the parts identified for replacement were the front enclosure, battery lock clip, bottom enclosure, top cover and the integrated encoder gearbox.In summary, the initial reported complaint that the bottom lower housing of the platform came apart was confirmed during visual inspection.The fault was found to be due to normal wear and tear.The observed ua 27 fault is unrelated to the initial reported complaint.The ua 27 was found to be due to a defective integrated encoder gearbox.

• 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: 4123627
• MDR Text Key: 4924441
• Report Number: 3010617000-2014-00498
• 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: 08/26/2014

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: Service and Testing Personnel
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2008
• 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