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

Model Number MODEL 100

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888)

Event Date 05/28/2015

Event Type  Injury  

Event Description

It was reported that the autopulse platform was used on a male patient on the evening of (b)(6) 2015.A call was dispatched and when the medics arrived on scene, the patient was on the couch.Medics moved the patient onto the floor and began manual cpr (exact length of time was not provided).The patient was placed onto the autopulse platform and the device was deployed without any issues.The platform performed active operation without any issues all the way into the emergency room (er).The patient was pronounced at the emergency room with his family present.After the autopulse was removed, the presence of blood and compound rib fractures were observed.The medics never saw anything abnormal during their time with the patient.No device malfunctions reported.No further information was provided.

Manufacturer Narrative

Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Event Description

Additional information was received from the customer on 06/19/2015, indicating that the patient was found lying in the supine position.Family members indicated that the patient had not feeling well all day and was experiencing difficulty breathing.Medics on scene observed that the patient had agonal respirations and no pulses.Therefore, cpr was initiated (exact length of time was not provided).The patient was moved from the couch onto the floor where the autopulse was applied.An elevation tube was inserted and placement was verified with an entitle co2 monitor as well as auscultation.An ekg monitor was also applied, which showed that the patient was in an asystolic state.An in squad io (intraosseous oxygen) was placed into the patient's right leg and two rounds of epinephrine and one round of atropine were administered.No changes with the patient's cardiac rhythm were observed.The platform performed active operation without any issues all the way into the emergency room (er).Patient was transported without incident or additional change in condition.Patient's care was transferred to the er staff.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation on 06/23/2015.Visual inspection of the returned platform was performed and no physical damages were observed.A lifeband was also returned for evaluation and visual inspection found that the liners were ripped at the connections to the hinged belt guard.A review of the platform's archive data was performed and found that no user advisories or warnings occurred on (b)(6) 2015.On the same day, it was observed that autopulse li-ion battery (21136) was used on a medium sized patient for a duration of more than 60 minutes and more than four thousand compression cycles with no faults or errors exhibited.When the platform was powered on the next day on the reported event date of (b)(6) 2015, a user advisory (ua) 45 (not at "home" after power-on/restart) message was displayed without the initiation of any compressions.Further inspection identified that the lifeband straps were not pulled completely out prior to turning the device on.Functional testing including a run_in test with a 95% patient test fixture was performed for several hours and no other user advisories or faults were exhibited.Load cell characterization testing was also performed, which found both load cells to be functioning within specification.The autopulse passed all final functional testing.The returned lifeband was also tested with a test autopulse platform and no functional issues or discrepancies were observed.In addition, the lifeband was deployed without any problems for approximately 60 minutes using a large resuscitation test fixture (lrtf) and no problems were found.The platform passed all testing criteria.Based on the investigation, no parts were identified for replacement.Based on the information received, the medics did not observe anything abnormal during the code.There were no device issues reported and the device evaluation did not identify any issues that may have caused or contributed to the outcome of the patient.Rib fractures and other injuries are a common but acceptable side-effect of cpr.They can be caused by manual cpr as well as with any method of mechanical cpr.In this case, the rib fractures could have happened due to manual cpr as well as during autopulse compressions or a combination of both.Additionally, in the american heart association (aha) and international consensus on cardiopulmonary resuscitation (ilcor) 2010 guidelines, the vigorous application of chest compressions is a class 1 recommendation (standard of care) while recognizing the high rates of adverse events.The guidelines state that this is the appropriate trade off because the alternative to vigorous chest compression is certain death.Common training is that broken ribs are a normal, expected and even beneficial adverse event to the ultimate goal of resuscitation.Multiple physician experts in the field of resuscitation have concluded that adverse events resulting from the application of cpr are not likely to increase the rate of death.Note: according to 11 different published reports standard manual cpr complications occur at rates of 33% rib fracture, which are comparable to rates with use of 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: 4860887
• MDR Text Key: 5845218
• Report Number: 3010617000-2015-00350
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2014
• 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): Other