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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform was returned to zoll on 04/10/2018 for investigation.However, investigation is still in progress.A supplemental report will be filed when 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, autopulse platform compressed well on a cardiac arrest patient until it stopped with ua19 when the crew stopped it for checking pulse.Manual cpr was applied during troubleshooting the platform.The user switch to manual cpr due to the autopulse continually didn't function properly.Rosc didn't achieved, and patient expired after a combination of mechanical and manual cpr.The customer stated that patient's death is not related to the autopulse.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.Mortality of out-of-hospital cardiac arrest (ohca) is high.Survival to hospital discharge, after ems-treated non-traumatic cardiac arrest with any first recorded rhythm was 9.8% for adults (aha statistical update 2013).In this event, death is attributed to ohca.Death is an expected outcome for ohca.

Event Description

During use on a patient for cardiac arrest, the user stopped the autopulse platform to check for pulse on the patient.When the platform was stopped, error message ua19 (max applied load exceeded) displayed.Manual cpr was applied during troubleshooting the platform.The user pulled up the lifeband and the ua19 was cleared.After the user cleared the ua19 error message, the use of the autopulse continued but it didn't function properly.The user switch to manual cpr but the patient did not achieved rosc.The customer stated that patient's death is not related to the autopulse.After the call, the customer reported that they encountered the same issue back at their station using a manikin.

Manufacturer Narrative

The report of ua 19 (max applied load exceeded) error messages occurring on the customer reported event date of (b)(6) 2018 was confirmed through analysis of the retrieved archive data from the autopulse platform (sn (b)(4).The archive data indicated that on the event date, the platform inserted with an adequately charged autopulse li-ion battery was used on a large patient weighing approximately 328 lbs.And displayed multiple ua 19 error messages.The cause of the ua 19 error messages is attributed to the driveshaft meeting resistance when the platform was operated on a large and stiff patient.The platform performed continuous compressions with a large resuscitation test fixture without error.There was no device malfunction observed.The investigation verified that the drivetrain motor brake gap was within the specification.A load characterization check was performed and confirmed that both load cell modules are functioning within the specification.Note that user advisory error messages are designed into the platform when one of several conditions is detected.The ua 19 error message recorded in the archive data is easily clearable by the user.The ua 19 error message alerts the operator that the load plate has detected too much weight being applied.The ua 19 error message can be cleared by restarting the platform.Based on the archive data, the ua 19 error messages were due to the platform being used with a patient beyond the recommended size parameters.The autopulse is designed for adults with weight of no more than 300 lbs (136kg), with a chest circumference of 29.9 to 51.2 inches (76 to 130 cm), and a chest width of 9.8 to 15 inches (25 to 38 cm).The returned platform was received with a damaged top cover; this observation is not related to the reported event.Historical complaints were reviewed for service information related to the reported complaint and no similar complaint was reported for the autopulse platform with serial number (b)(4).The previous assessment is not changed.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, autopulse platform compressed well on a cardiac arrest patient until it stopped with ua19 when the crew stopped it for checking pulse.Manual cpr was applied during troubleshooting the platform.The user switch to manual cpr due to the autopulse continually didn't function properly.Rosc didn't achieved, and patient expired after a combination of mechanical and manual cpr.The customer stated that patient's death is not related to the autopulse.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.Mortality of out-of-hospital cardiac arrest (ohca) is high.Survival to hospital discharge, after ems-treated non-traumatic cardiac arrest with any first recorded rhythm was 9.8% for adults (aha statistical update 2013).In this event, death is attributed to ohca.Death is an expected outcome for ohca.

• 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: 7488483
• MDR Text Key: 107602784
• Report Number: 3010617000-2018-00492
• 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: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• 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: 04/10/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1