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

Model Number MODEL 100

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.In this case, during patient use the autopulse platform stopped compressions due to the over temperature error.The crew member inadvertently blocked the air vent of the platform with the knee causing the device to overheat and shut down.Manual cpr was immediately performed for 30 seconds during platform restart.The platform was used again without issues for an unknown period of time.The return of spontaneous circulation (rosc) was not achieved.The cause of the patient's cardiac arrest was not specified.The autopulse was intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the user reverts to manual cpr.The transition from autopulse to manual cpr by trained users is similar to the time necessary for rescuer rotation, and presents the same workflow as manual cpr.Hence, based on available information, the patients' outcome was not negatively impacted by the interruptions when compared to standard of care manual cpr.In this event, death is attributed to out-of-hospital cardiac arrest (ohca).Death is an expected outcome for ohca.

Event Description

As reported, during patient use the autopulse platform stopped compressions due to the over temperature error.The crew member inadvertently blocked the air vent of the platform with the knee causing the device to overheat and shut down after 5 minutes of operation.Manual cpr was immediately performed for 30 seconds during platform restart.The platform was used again without issues for an unknown period of time.Additional information received on (b)(6) 2018 from customer stating that return of spontaneous circulation (rosc) was not achieved and the patient was pronounced dead at the hospital and the incident occurred on (b)(6) 2018.According to the reporter, the patient's death was not related to the delay caused by the device issue.The cause of the patient's cardiac arrest was not specified.No further information was provided.Customer not aware of the platform sn used during the call.Two platforms sn (b)(4) returning for evaluation.See mfr 3010617000-2018-00805 for autopulse platform sn (b)(4).Received medwatch report on 6/15/2018: mw5077674.

Manufacturer Narrative

The customer's reported complaint of the autopulse platform overheat and shut down after the air vent was blocked by a crew member's knee was confirmed in the archive review.The root cause of the issue was due to user error.Functional testing was performed and found no issue.There were no device deficiencies found during the evaluation of the platform.The autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.Review of the archive data show user advisory (ua) 11 (max patient temperature exceeded) error messages occurred on the reported event date.User advisory (ua) 11 (max patient temperature exceeded) alerts the operator that the patient contact surface temperature sensor is outside of the normal range of 45°c during power-on-self-test or during take up.Factors such as ambient storage condition (e.G., a fire truck in sun) or soft surface that may block air vents are known to cause platform to overheat.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse platform sn (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7760185
• MDR Text Key: 116899216
• Report Number: 3010617000-2018-00804
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Date Manufacturer Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1