MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE® NIMH BATTERY

Model Number 8700-0702-03

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Code Available (3191)

Event Date 01/02/2014

Event Type  malfunction  

Event Description

Customer received an emergency call on (b)(6) 2014 and dispatched an ambulance helicopter.After 26 minutes, the ambulance crew (physician and nurse) arrived on scene to find a (b)(6) female patient with pulmonary embolism.The patient had cardiac pulmonary arrest (cpa) prior to the crew's arrival.The crew deployed the autopulse platform.After a few minutes, the platform displayed a "low battery" message.The battery was swapped with a spare battery.After this, the crew paused the platform for a rhythm check and then attempted to restart compressions by pressing the "start/continue" button.However, the platform did not restart.The crew powered the device off and then back on 4 times.Each time the platform was powered back on, compressions were resumed.After that, the platform continued compressions for the duration of transport to the hospital, which was 10 minutes.The patient did not achieve return of spontaneous circulation (rosc) during transport.Customer reported that the patient was hospitalized on the ninth day due to the reported pulmonary embolism.The physician did not attribute the patient's hospitalization to the use of the autopulse.No further information was provided.

Manufacturer Narrative

The crew noted that during the morning shift check, the platform's battery charge status indicated that the battery was fully charged.The product in complaint was returned to zoll on 01/24/2014 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.Please see the following related mfr.Reports: 3003793491-2014-00071 for autopulse® resuscitation system model 100 with sn: (b)(4); 3003793491-2014-00072 for autopulse® nimh battery with sn: (b)(4); 3003793491-2014-00074 for autopulse® nimh battery with sn: (b)(4).

• Brand Name: AUTOPULSE® NIMH BATTERY
• Type of Device: NIMH 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: 3615904
• MDR Text Key: 4159270
• Report Number: 3003793491-2014-00073
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 01/14/2014

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: 8700-0702-03
• Device Catalogue Number: 8700-0702-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2014
• Initial Date FDA Received: 02/08/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 66 YR
• Patient Sex: Female