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 08/28/2019

Event Type  Injury  

Manufacturer Narrative

Zoll has received four autopulse platforms for investigation.The autopulse platform used during the event is unknown.A supplemental report will be filed once further information is available.Conclusion of the death and event multiple injuries: based on zoll medical safety assessment, 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.In this case, a female patient in cardiac arrest from a possible drowning was discovered in unconscious, unresponsive, pulseless, and apneic.Manual cpr was performed on the floor before autopulse was used.With no visible land marks, the king airway was inserted.After 30 minutes and with no response, the auto pulse device was removed and manual cpr continued.The return of spontaneous circulation (rosc) was not achieved and the patient was pronounced dead at the scene.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 coroner's office for three different patient's and these injuries were not assigned to any particular patient.Per coroner, it's difficult to determine whether the patient's outcome was due to the circumstances of the death or the device.Mfr 3010617000-2019-00980 and mfr 3010617000-2019-00981 were created for other two patient's.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, however, the event of "death" was not related to the autopulse device since the device did not malfunction during use.

Event Description

Patient #1: the crew responded to a female patient in cardiac arrest from a possible drowning.The patient was discovered by her husband under water in the bathtub face down, he removed her from the tub and performed manual cpr on the floor.Patient had widespread cyanosis noted with deep blue coloration to her lips and face.Her abdomen was distended and firm.She was unconscious, unresponsive, pulseless, and apneic.Her pupils were non-reactive and dilated.The medical response crew arrived on the scene and took over compressions from the husband.They placed the patient on the autopulse platform.After 30 minutes with no errors or faults and with no patient's response, the autopulse device was removed to continue manual cpr.The return of spontaneous circulation (rosc) was not achieved and the patient was pronounced dead at the scene.The patient had a medical history of alcohol abuse and depression.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 coroner's office for three different patients and these injuries were not assigned to any particular patient.Per coroner, it's difficult to determine whether the patient's outcome was due to the circumstances of the death or the device.Mfr 3010617000-2019-00980 and mfr 3010617000-2019-00981 were created for other two patients.

Event Description

Please see the following related mfr report: (b)(6) - mfr 3010617000-2019-00981 for patient # 2, and (b)(6) - mfr 3010617000-2019-00980 for patient # 3.

Manufacturer Narrative

Zoll has received four autopulse platforms with sn (b)(4) and (b)(4) for investigation.Out of the four autopulse platforms, three platforms with sn (b)(4) and (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.

• 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: 9209296
• MDR Text Key: 162883142
• Report Number: 3010617000-2019-00984
• 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 Weight: 64