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

Model Number MODEL 100

Device Problems Defibrillation/Stimulation Problem (1573); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Event Description

It was reported that the autopulse platform was unable to perform compressions on three attempts.No adverse patient sequelae was reported.Customer also reported that they were able to reproduce the issue on (b)(4) 2014 while using two mannequins.The platform displayed user advisory (ua) 17 (max motor on time exceeded during active operation) and ua 46 (software error) messages.Customer indicated that there were no damages to the lifeband.No further information was provided.Please note that the date of event was not 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

Please note that updates were made to the following sections: 1.Section d.Box 4.Serial # 2.Section h.Box 4.Device manufacture date the autopulse platform in complaint was returned to zoll on 11/03/2014 for investigation.Investigation results as follows: visual inspection of the returned platform shows that the encoder cover was damaged.The physical damage found during visual inspection is not related to the reported complaint of a user advisory (ua) 17 (max motor on time exceeded during active operation) and fault 46 (software error).The physical damage appears to have been caused by normal wear and tear (autopulse manufactured in april of 2009).A review of the autopulse platform's archive was performed and confirmed the reported complaint.The date of event was not provided by the customer.However, the archive data shows that ua 17 and fault 46 occurred on (b)(6) 2014.Functional testing was performed and did not confirm the reported complaint.Load cell characterization testing was performed and indicated that both load cell modules were functioning within specifications.The platform was subjected to a run-in test for several hours with a 95% patient test fixture and good batteries.No faults or errors were observed during testing.Based on the investigation, the part identified for replacement was the front cover.In summary, the reported complaint of a ua 17 and fault 46 was confirmed based on the platform's archive review but was not reproduced during functional test.The root cause for ua 17 and fault 46 could not be determined.Per the autopulse maintenance guide, ua17 is an indication that the lifeband is twisted or battery voltage is low.Based on the review of the platform's archive, it was observed that the battery was fully charged when the ua 17 fault occurred.Therefore, a twisted lifeband could be likely to contribute to the ua 17 fault.Upon replacement of the front cover, the platform was re-evaluated through functional testing and passed all testing criteria.

• 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: 4136972
• MDR Text Key: 4913733
• Report Number: 3010617000-2014-00500
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2009
• 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