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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 05/05/2018

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (sn (b)(4)) was returned to zoll on 18 jun 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, the autopulse platform (sn (b)(4)) displayed a user advisory (ua) 2 (compression tracking error) error message and stopped compression after used on a cardiac arrest patient with continuous compression for approximately 10 minutes.The crew immediately reverted to manual cpr.The user restarted the platform using a fully charged autopulse li-ion battery, the platform stopped compression and displayed ua 2 error message again at unspecified time.The crew immediately performed manual cpr.A return of spontaneous circulation (rosc) was not achieved.The patient was pronounced deceased.The user did not attribute the death of the patient on the autopulse platform.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, the autopulse platform (sn (b)(4)) was used on a cardiac arrest patient operating with continuous compression for approximately 10 minutes.The platform displayed a user advisory (ua) 2 (compression tracking error) error message and stopped compression.The crew immediately performed manual cpr.The user was able to restart the platform using a fully charged autopulse li-ion battery; at unspecified time the platform stopped compression and displayed ua 2 error message again.The crew immediately performed manual cpr.A return of spontaneous circulation (rosc) was not achieved.The patient was pronounced deceased.The user did not attribute the death of the patient on the autopulse platform.It was later reported that the ua 2 displayed repeatedly, at the patient's home and during ambulance transport to the hospital.Each time, the user was able to clear the error message.The emergency team were experienced autopulse users.Additionally, they were unable to reproduce the fault at the station.

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(4)) displayed a user advisory 2 (compression tracking error) message and stopped compression was confirmed based on the archive review and during functional testing.The fault was found to be due to the defective power distribution board.Following service, including replacement of the front enclosure, battery lock, pcb support brackets, and the power distribution board, the platform passed all testing criteria.Visual inspection was performed and found two stripped pcb support brackets, a broken battery lock and a cracked front enclosure.The physical damage found during visual inspection is considered unrelated to the reported event.The autopulse platform is a reusable device and was manufactured on 12/31/2015.The physical damage found is a characteristic of normal wear and tear of the device.A review of the archive was performed and the reported complaint of ua2 error message was confirmed.Functional testing was performed and the reported issue of ua2 error message was confirmed.Upon powering up the platform, ua2 error message was displayed on the display panel screen.Device history record (dhr) was reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (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: 7625770
• MDR Text Key: 112497444
• Report Number: 3010617000-2018-00660
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• 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: 8700-0740-08
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1