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

Model Number MODEL 100

Device Problems Sticking (1597); Malposition of Device (2616); Device Operates Differently Than Expected (2913)

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

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 #: 3010617000-2014-00436 which addresses the first reported issue against autopulse® li-ion battery with sn: (b)(4).Additional information obtained from zoll clinical education manager indicated that the reported issue against the autopulse platform was a training issue.Customer was not aligning the driveshaft up with the "home" position when attempting to take the lifeband out.The autopulse platform in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.However, the autopulse archive data was received by zoll for evaluation.A supplemental report will be filed once evaluation of the platform's archive data has been completed.

• 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: 4032621
• MDR Text Key: 15180300
• Report Number: 3010617000-2014-00437
• 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
• Report Date: 06/17/2014

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: 8700-0700-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2014
• Initial Date FDA Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2008
• 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
• Treatment: MANUAL CPR