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

Model Number MODEL 100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 09/07/2019

Event Type  Injury  

Manufacturer Narrative

Zoll has received four autopulse platforms for investigation.The autopulse platform used during the patient use is unknown.A supplemental report will be filed when the investigation has been completed.Event: multiple injuries.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common skeletal injuries (rib, sternum and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax) are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.The aha guidelines 2000 states, "even properly performed chest compressions can cause rib fractures in adult patients." the guidelines further state, "concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death." the recently released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest." the 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions, and recommends to ensure adequate compression rates and adequate compression depth.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.The event of "multiple injuries" was possibly related to the autopulse device since the connection of the reported injury to using autopulse cannot be ruled out.Event: death.The patient's death was not related to the autopulse device.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common skeletal injuries (rib, sternum and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax) are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.Based on available information, the death was not related to the autopulse device.Out-of-hospital cardiac arrest (ohca) is one of the main causes of death in industrial nations.About 25% of patients survive this event and make it to the hospital, and even fewer patients survive after 24 hours (nichol, nejm, 2015).In the united states, survival to hospital discharge after non-traumatic emergency medical services-treated cardiac arrest with any first recorded rhythm was 10.6% for patients of any age.Of the bystander-witnessed out-of-hospital cardiac arrests in 2011, 31.4% of victims survived to hospital discharge (mozaffarian, circulation, 2016).Death is an expected outcome for ohca.

Event Description

Patient # 3: the crew responded to a (b)(6) year old female patient in cardiac arrest.The patient had no medical history and has not been feeling ill or sustained any recent injuries.Incident occurred at home and the cardiac arrest was witnessed by the family members.Per family member, the patient was shaking and foaming at the mouth prior to the cardiac arrest.Bystander cpr was performed by a family member for approximately 10 minutes prior the ems arrival.The patient was pale and had apneic respirations.No signs of trauma, lividity, or rigor mortis.Cpr was taken over by the crew.The patient was placed on the autopulse platform and the compressions were performed for 30 minutes without any error or fault.The crew checked the pulse of the patient for every 2 minutes throughout the resuscitation process.The patient was ventilated every 8 seconds via bvm (bag valve mask) and opa (oropharyngeal airway).Rosc (return of spontaneous circulation) was achieved and the patient was extricated from the scene on the platform and loaded in the ambulance for transport to the hospital.Upon loading, the patient lost pulse and the compressions were resumed with the autopulse platform throughout the transport.The patient was pronounced dead at the hospital.Coroner's office reported 3 injury cases.However, coroner's office did not provide details of individual patient and injury.The only statement available said: multiple injuries (hemorrhage to the diaphragm, hemorrhage to the kidney, lacerated spleen, lacerated liver, blood in the abdominal cavity, bilateral rib fractures, bruising to the small bowel and abrasions to the lateral chest) were reported by the coroner's office for three different patients and these injuries were not assigned to any particular patient.Per coroner's office, it's difficult to determine whether the patient's outcome was due to the circumstances of the death or the device.Ccr (b)(4) and ccr (b)(4) were created for other two patients.Please see the following related mfr report: mfr 3010617000-2019-00984 for patient # 1.Mfr 3010617000-2019-00981 for patient # 2.

Manufacturer Narrative

Zoll has received four autopulse platforms with sn (b)(4) for investigation.Out of the four autopulse platforms, three platforms with sn (b)(4) showed no device malfunction during the testing.The autopulse platforms passed the functional testing without any fault or error and worked as intended.The autopulse platform is designed to stop when motor fault is detected to ensure safe and optimum cpr.The autopulse platform with sn (b)(4) failed run-in test due to user advisory (ua) 17 error message, unrelated to the reported patient injuries.The root cause for the ua17 error message was due to the defective drive train motor.The drive train motor was replaced to address the ua17 error.After replacement, the autopulse platform passed the final testing without any fault or error.The connection between the four autopulse platforms and the reported patient injury could not be ruled out.The archive data review of the autopulse platforms didn't show any out of specification operating parameters.So, it is likely that the autopulse platform didn't cause the reported injuries.Manual cpr was performed prior to the use of autopulse platform.

Event Description

Please see the following related mfr report: (b)(6) - mfr 3010617000-2019-00984 for patient # 1, and (b)(6) - mfr 3010617000-2019-00981 for patient # 2.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 9208765
• MDR Text Key: 162883835
• Report Number: 3010617000-2019-00980
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

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?: 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: 09/27/2019
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 113