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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 02/15/2015

Event Type  malfunction  

Event Description

It was reported that during patient use, the autopulse platform did not work.No specific details were provided.However, patient reportedly expired.No further information was provided.Manufacturer has requested additional information; however, no additional information has been obtained.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(6) 2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform are as follows: visual inspection of the returned platform was performed and found no visible or physical damages to the platform.A review of the platform's archive data was performed and found that the data was partially corrupted.Therefore, information on the reported event date ((b)(6) 2015) could not be retrieved and the customer's reported complaint of the platform displaying a "system error" message could not be confirmed.The customer's reported complaint of a "system error" message was not duplicated during functional testing of the returned platform.It should be noted that the customer also returned li-ion battery with serial number (sn) (b)(4).However, the customer did not allege any deficiencies against the battery.The returned battery was charged and test cycled without any issues.A run_in test was performed using a 95% patient test fixture and the returned li-ion battery for more than 30 minutes without any faults or error messages observed.Another run_in test was performed using a 95% patient test fixture and other fully charged test batteries for several hours without any issues.A load cell characterization test was also performed which verified that both load cell modules were functioning within specification.Based on the investigation, no parts were identified for replacement.In summary, the customer's reported complaint of the platform displaying a "system error" message could not be confirmed through review of the platform's archive data because the data was partially corrupted.There were no device deficiencies found during evaluation of the returned platform which could have caused or contributed to the reported complaint.The platform successfully passed all initial and final functional testing without any issues.Therefore, a root cause could not be determined.There were also no device deficiencies found during evaluation of the returned platform which could have caused or contributed to the reported patient death.The additional information provided by the customer indicated that the cause of the cardiac arrest was hypoxemial bilateral pulmonary disease.Per the doctor's opinion, the patient's death was not related to the autopulse.

Event Description

Additional information obtained from the customer: the date of the event was (b)(6) 2015, and not (b)(6) 2015.On (b)(6) 2015, an (b)(6) female patient showed pulmonary disease with respiratory distress, progressing to a cardiac arrest.Patient was (b)(6).Patient had no medical history and was not taking any medications.Bystander cpr was initiated by the patient's mother under instructions from the ems.Patient was asystole.Return of a cardiac rhythm was achieved after 20 minutes of manual cpr and 4 mg of adrenaline.Patient was transported to the hospital via helicopter.On arrival to the intensive care unit, patient was unstable in terms of hemodynamics and was rapidly showing another cardiac arrest.Manual cpr was initiated as the hospital staff prepared the autopulse platform for deployment.The platform displayed a "system error, out of service, revert to manual cpr" message upon power on.No compressions were provided by the autopulse.The platform was powered off then back on 3-4 times; however, the message did not clear.Manual cpr was performed during this time.Use of the platform was then discontinued.The autopulse was replaced with a lucas, another automated resuscitation device.In addition, a peripheral circulation support of extracorporeal membrane oxygenation (ecmo) type was provided.However, return of spontaneous circulation (rosc) was not achieved.The doctor's pronounced the patient dead on (b)(6) 2015 at 7:00 pm.An autopsy was performed; however, the customer indicated that the autopsy report cannot be provided due to hospital confidentiality.The cause of the cardiac arrest was hypoxemial bilateral pulmonary disease.In the doctor's opinion, the patient's death was not related to the autopulse.

• Brand Name: AUTOPULSE® RESUSCITATION 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: 4922986
• MDR Text Key: 6055620
• Report Number: 3010617000-2015-00397
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• 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: 8700-0700-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2005
• 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: 18 YR
• Patient Weight: 75