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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762); Death (1802); Loss of consciousness (2418)

Event Date 02/21/2015

Event Type  malfunction  

Event Description

Ems received a call on (b)(6) 2015 regarding a (b)(6) year old female patient weighing around 80 kg.Information on the patient's height, medical history and medications was not provided by the physician.No information is available for the time prior to arrival of the ambulance.After arrival of the ambulance, the crew requested a helicopter for the patient.Patient details were not provided.The hospital physician stated that ems only calls for the hospital's helicopter when the patient has a high possibility to be recovered.Transport time via ambulance to the helicopter and wait time for the helicopter was not provided.While waiting for the helicopter's arrival, patient had cardiopulmonary arrest (cpa).The arrest was witnessed by the ems crew, who then initiated manual cpr (exact length of time was not provided).Patient was unconscious when the helicopter arrived.The autopulse platform was deployed in the helicopter without any issues.The platform performed a few compressions, then stopped and displayed a user advisory 27 (encoder fault).The helicopter staff discontinued use of the platform and immediately reverted to manual cpr for about 15-20 minutes.Advanced cardiovascular life support (acls) was provided by the helicopter staff.It is unknown what time the patient arrived at the hospital.After 30-40 minutes from the time of helicopter pick up, patient achieved return of spontaneous circulation (rosc) in the hospital on the same day.However, patient later died the next day ((b)(6) 2015).An autopsy was not performed.Per the hospital doctor, the cause of the cardiac arrest and the patient's death was pulmonary embolism (pe).It is unknown what the physician based his decision of pulmonary embolism on.No further information was provided.

Manufacturer Narrative

A physician at the hospital confirmed that the autopulse lifeband was reused at the time of the event.The lifeband had been reused about 2-3 times.After the reported event, the hospital staff tested the platform with a mannequin and received an error code 19 (max applied load exceeded).The cause of the reported pulmonary embolism (pe) is unknown but not device related.The autopulse platform in complaint was returned to zoll on 03/04/2015 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 and lifeband as follows: visual inspection of the returned platform was performed and no physical damages were noted.The lifeband used during the reported event was also returned for evaluation.The lifeband was not received in its original packaging.The compression pad was received dirty.Further visual inspection of the lifeband revealed multiple creases and twists on the surface of the belt guard indicating that the unit was used multiple times.The rub guard liner that connects to the top compression pad of the left belt guard cap was completely torn, ripped and broke apart from the cover plate.The left belt detached from the guard liner and the butterfly clip hinge was found to be broken.No other issues were observed.Please note that the results of the visual inspection of the lifeband are unrelated to the reported complaint.The platform underwent initial functional testing with no faults or errors exhibited.A review of the platform's archive data was performed which found the following user advisory (ua) codes on the reported event date of (b)(6) 2015: ua 18 (max take-up revolutions exceeded), ua 19 (max applied load exceeded), ua 27 (encoder fault (speed > 3000 rpm)), ua 34 (encoder failure), and ua 45 (not at "home" position after power-on/restart).Consistent with the reported information, the archive data indicates that multiple ua 27 codes occurred while the platform was being used on a patient.The archive also shows multiple ua 45 codes occurring during patient use.No device deficiencies were observed which could have caused or contributed to the ua 27 and ua 45 codes.Based on inspection of the device, the integrated encoder gearbox was replaced as a precaution to address the ua 27 codes.The ua 45 codes were likely exhibited due to the lifeband straps not being fully extended prior to pressing start.The archive shows that after patient use, the platform exhibited a ua 18 code as intended due to the customer storing the lifeband in the ready position.The data shows that the platform was then powered on again approximately 1 hour later.Consistent with the reported information provided, the data shows the platform was used to perform compressions on a test manikin, at which time it exhibited multiple ua 19, ua 34, and ua 45 codes.A cause for the ua 19 codes could not be identified as no device deficiencies were observed with the platform.Specifically, load cell characterization was performed which showed that both load cells were functioning within specification.A cause for the ua 34 could not be determined; however, the integrated encoder gearbox was proactively replaced to address it.Based on the investigation, the part identified for replacement was the integrated encoder gearbox.The platform then underwent and passed all final functional testing.In summary, the reported complaint of the platform displaying a ua 27 code was confirmed through platform archive review.No device deficiency was identified that may have caused the ua 27 codes; however, the integrated encoder gearbox was replaced as a precaution.The archive then showed that after patient use, the platform exhibited a ua 18 code as intended due to the customer storing the lifeband in the ready position.The archive also showed that multiple ua 19, ua 34, and ua 45 codes were exhibited after patient use.A cause for the ua 19 codes could not be identified as no device deficiencies were observed with the platform.Specifically, load cell characterization was performed which showed that both load cells were functioning within specification.A cause for the ua 34 could not be determined; however, the integrated encoder gearbox was proactively replaced to address it.The ua 45 codes were likely exhibited due to the lifeband straps not being fully extended prior to pressing start.The lifeband used during the reported event was also returned for evaluation.The compression pad was received dirty.Further visual inspection of the lifeband revealed multiple creases and twists on the surface of the belt guard indicating that the unit was used multiple times.The rub guard liner that connects to the top compression pad of the left belt guard cap was completely torn, ripped and broke apart from the cover plate.The left belt detached from the guard liner and the butterfly clip hinge was found to be broken.No other issues were observed.Please note that the results of the visual inspection of the lifeband are unrelated to the reported complaint.Based on the platform inspection, there were no device deficiencies which could have caused or contributed to the reported patient outcome.Per the hospital doctor, the cause of the cardiac arrest and the patient's death was pulmonary embolism.The cause of the pulmonary embolism is unknown, however is unrelated to the device.

• 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: 4625117
• MDR Text Key: 5570663
• Report Number: 3010617000-2015-00164
• 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,Followup
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2015
• 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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2010
• 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 Age: 51 YR
• Patient Weight: 80