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

Model Number MODEL 100

Device Problem Loss of Power (1475)

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

Event Date 07/20/2014

Event Type  malfunction  

Event Description

Complainant alleged that the autopulse® platform had no power.The platform may have been dropped.No adverse patient sequelae was reported.No further details were provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for analysis.Visual inspection of the returned platform shows that the top cover, encoder cover, motor cover, head restraint brackets, restraint pin assembly, and the battery compartment were damaged.In addition, the battery partition cover was missing.The physical damages found during visual inspection are not related to the reported complaint that the platform had no power.The damages appear to have been caused by user mishandling (i.E.Dropping the platform).A review of the autopulse archive was performed and the reported complaint was not confirmed.The archive data shows that no clinical event with a patient occurred on the reported event date of (b)(6) 2014.Functional testing was performed and the reported issue could not be reproduced.The platform was able to power on and off many times with no problems.The platform also ran for 15 minutes with the test mannequin and 7 minutes with a large resuscitation test fixture (lrtf) without a fault.During testing, it was also observed that one of the load cells was not functioning properly.However, this is not related to the reported complaint.Based on the investigation, the parts identified for replacement were the top cover, battery partition cover, motor cover, encoder cover, head restraint brackets, restraint pin assembly, load cell module and the battery compartment.In summary, the reported complaint was not confirmed based on the archive review and during functional testing.The physical damages found during visual inspection are unrelated to the reported complaint.Upon replacement of all damaged parts, the platform was re-evaluated through functional testing and the platform 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: 4004120
• MDR Text Key: 4951668
• Report Number: 3010617000-2014-00408
• 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: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2014
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2006
• 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