MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE® LI-ION BATTERY

Model Number 8700-0752-01

Device Problems Sticking (1597); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

It was reported that during use on a medium-sized, male patient weighing between (b)(6) pounds, the autopulse li-ion battery gave a short run time of approximately 10 minutes.Manual cpr was performed prior to autopulse usage for about 2 minutes.Customer also reported that the white lifeband retaining ring on the autopulse platform was sticking in the retracted position.The retaining ring did not click down into place after a new lifeband was placed on the platform.In addition, the platform did not recognize the presence of the new lifeband.Customer was able to manually "unstick" the retaining ring by prying it down; however, it was "sticky".No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

Please see the following related mfr.Report #: 3010617000-2014-00437 which addresses the second reported issue against autopulse® resuscitation system model 100 with sn: (b)(4).Zoll has not yet received the autopulse battery 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 battery was returned and evaluated.The reported complaint could not be confirmed.Visual inspection was performed and no damages were observed.The battery passed all testing criteria.A review of the battery's archive was also performed and it was determined that the battery performed as intended.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY
• 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: 4032610
• MDR Text Key: 4804542
• Report Number: 3010617000-2014-00436
• 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: Paramedic
• Type of Report: Initial,Followup
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0752-01
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: MANUAL CPR