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 Problems Bone Fracture(s) (1870); Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 06/25/2018

Event Type  Injury  

Manufacturer Narrative

In the adverse incident report, there was no report of an autopulse platform (sn unknown) malfunction.The platform will not be returned for evaluation and therefore, an investigation cannot be performed.Also, there was no information related to patient injuries received from the road traffic incident.However base on the available information, the injuries were severe enough to cause patient death.In agreement with the customer, the event death was not related to the autopulse device.Based on zoll's medical safety assessment, the fractures (rib fracture or thoracic spine fracture) are expected adverse events for both manual and mechanical cprs.Two large randomized clinical trials (circ, linc) showed no difference in the event rate for rib fracture between the manual compression arms and the mechanical compression arms.The safety monitoring boards for both studies determined there was no new risks identified and no risk concerns with the trials.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." in this case, device was used on an (b)(6) -year-old female who had been involved in a road traffic incident.Pathologist subsequently the autopulse found evidence of rib fracturing and thoracic spine fracture with spinal cord injury which appear to be greater than that seen with manual cpr, and they think it is possible that her bones were osteoporotic and therefore much more likely to fracture.Although cause of death was certified as being natural causes, pathologist has flagged that 'age is therefore possibly a factor to be considered before deploying the device'.Rib fracture and spine fracture can be caused by manual cpr as well as with the mechanical cpr, especially in this predisposed patient who was an (b)(6) -year-old female and was possible that her bones were osteoporotic.The traffic incident can also contribute to development of fracture.In the same time the connection of the reported injury to using autopulse cannot be ruled out.The event of rib fracture and thoracic spine fracture was possibly related to the autopulse device.

Event Description

Per incident report, during patient use on an (b)(6) -year-old female who had been involved in a road traffic incident.Pathologist subsequently found evidence of rib fracture and thoracic spine fracture with spinal cord injury which appeared to be greater than what is seen with manual cpr.It is possible that her bones were osteoporotic and therefore much more likely to fracture.Although cause of death was certified as being natural causes, pathologist has noted up that 'age is therefore possibly a factor to be considered before deploying the device'.The patient expired on (b)(6) 2018.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• 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: kim nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7963227
• MDR Text Key: 123671486
• Report Number: 3010617000-2018-01008
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2018

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: 8700-0740-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 85 YR