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 Code Available (3191)

Event Date 06/04/2014

Event Type  malfunction  

Event Description

It was reported that during a cardiac arrest, the autopulse platform powered off on its own after 15 compressions.Customer reverted to manual cpr (exact length of time was not provided).Another device was used to continue therapy.Caller had no patient information but reported that there were no adverse patient sequelae.No further information was provided.

Manufacturer Narrative

Customer also stated that new fully charged batteries were used at the time of the event.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

The autopulse platform in complaint was returned to zoll on 07/08/2014 for investigation.Investigation results as follows: visual inspection of the returned platform shows no visible or physical damages to the platform.A review of the autopulse archive was performed and the reported complaint of the autopulse platform shutting off on its own after 15 compressions was not confirmed.The archive data shows that no clinical event with a patient occurred on the reported event date of (b)(6) 2014.In addition, the archive also shows that deployment occurred between (b)(6) 2014 with no issues observed for uncommanded shut offs.Functional testing was performed and the reported issue was not reproduced.The platform passed the initial system test.Additional testing of the platform was performed with a 95% patient test fixture and good batteries for several hours and no faults or errors were observed.Based on the investigation, no parts were identified for replacement.In summary, the reported complaint of the autopulse platform shutting off on its own after 15 compressions was not confirmed based on the archive review and during functional testing.The platform was 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, 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: 3900962
• MDR Text Key: 15361468
• Report Number: 3003793491-2014-00297
• 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: Paramedic
• Type of Report: Initial,Followup
• Report Date: 06/05/2014

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 06/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2011
• 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