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

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Cardiac Arrest (1762); Death (1802); Dyspnea (1816)

Event Date 02/08/2014

Event Type  Death  

Event Description

Customer received a call regarding a (b)(6) year old male patient, weighing 180 pounds who was experiencing difficulty breathing.A family member witnessed the arrest, however, bystander cpr was not performed.Length of time that the patient was down is unknown.An ekg was performed, which indicated that the patient was in an asystolic condition.The autopulse platform was deployed without any issues.The platform stopped after 15 minutes of compressions and displayed a "system error - out of service" message.Customer changed the battery and restarted the platform but the issue did not resolve.The crew continued with manual cpr for 30 minutes, which included transportation time to the hospital.Return of spontaneous circulation (rosc) was never achieved.The hospital was 20 minutes from where the incident occurred.Patient continued to be treated in the emergency room and was administered medications.However, manual compressions were not performed by the staff.The patient was pronounced dead in the hospital by the physician.Customer could not provide the cause of the patient's death and the exact date of death.In addition, customer does not know if an autopsy was performed or if a report is available.Information regarding patient history was not provided.In addition, it is unknown if the patient's death is attributed to the autopulse usage.

Manufacturer Narrative

The product in complaint was returned to zoll on (b)(4) 2014 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection of the returned platform shows no damage.A review of the archive was performed and the reported complaint of the platform displaying a "system error - out of service, revert to manual cpr" message was confirmed.The archive data shows that system error 132 (internal watchdog timeout) occurred multiple times on the reported event date of (b)(6) 2014.Functional testing was performed and the reported issue was observed.Upon power up of the platform, a "system error - out of service, revert to manual cpr" message was displayed.The error message was cleared.Load cell characterization testing was performed and demonstrated that both load cell modules were functioning within specifications.The platform was also subjected to a run-in test using a (b)(6) patient test fixture and good batteries for several hours with no faults or errors observed.Due to the observed "system error - out of service, revert to manual cpr" (system error 132), as a precaution, the part that was identified for replacement was the processor pca board.In summary, the reported complaint of the platform displaying "system error - out of service" message was confirmed based on the archive review and during functional testing.Upon clearing the error message and replacement of the processor pca board as a pre-caution, the platform passed all testing criteria.Although it is unknown if the patient's death is attributed to the autopulse usage, rosc (return of spontaneous circulation) was never achieved with either methods of compressions (manual or mechanical).Additionally, ekg taken prior to autopulse deployment showed that the patient was asystolic.Survival rates in a cardiac arrest patient with asystole are extremely low.

• 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: 3668507
• MDR Text Key: 15199493
• Report Number: 3003793491-2014-00123
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 03/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2011
• 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
• Treatment: MANUAL CPR
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Weight: 82