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 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) displaying a user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message was reproduced during functional testing and confirmed during archive data review.The root cause was due to the driveshaft not being in home position.The archive data was reviewed and confirmed the occurrence of the ua 45 error message on the reported event date of (b)(6) 2018.Evaluation of the platform during initial power up, revealed a ua 45 error message on the user control panel.It was indicated that the driveshaft was not in home position.Using the administrative menu, the driveshaft was readjusted back to home position.The platform was further tested and passed all final specification without error.As part of routine service during testing, the device was examined and found no physical damage.However; the drive shaft exhibits binding and resistance, unrelated to the reported complaint.Clutch plate deburring was performed to remedy the binding and resistance.The autopulse platform is a reusable device and was manufactured on 13 mar 2008 it has exceeded its expected service life of 5 years, the device is over 10 years old.Note that user advisory error messages are designed into the platform when one of several conditions is detected.Ua 45 alerts the operator that the autopulse driveshaft is not at its home position when the platform was powered on.This user advisory will persist until the driveshaft is returned to its home position.Per the autopulse user guide instruct, to clear ua 45, the operator needs to pull up the lifeband until the chest bands are full extended.This action will move the driveshaft to its home position.Historical complaints were reviewed for service information related to the reported complaint and there was two similar complaint reported for autopulse with serial number (b)(4).(b)(4), reported on 15 may 2013, the drive shaft was rotated back to "home" position to remedy the issue.(b)(4), reported on 24 oct 2017, the drive shaft was rotated back to "home" position to remedy the issue.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, upon the crew arrived to a patient in cardiac arrest, the patient was assessed unresponsive and the autopulse platform (sn (b)(4)) was deployed successfully.Approximately 8 minutes after, the platform displayed a user advisory (ua) error message on the user control panel.The crew immediately performed manual cpr.A return of spontaneous circulation (rosc) was not achieved.The patient arrived at the hospital after 37 minutes, where the patient was pronounced dead.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 crew arrived on the scene in response to a patient in cardiac arrest.Upon arrival, the patient was assessed unresponsive and the autopulse platform (sn (b)(4)) was deployed successfully.Approximately 8 minutes after, the platform displayed a user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message on the user control panel.The crew immediately performed manual cpr.A return of spontaneous circulation (rosc) was not achieved.The patient arrived at the hospital after 37 minutes, where the patient was pronounced dead.The cause of cardiac arrest was not specified.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• 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: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7575964
• MDR Text Key: 110348069
• Report Number: 3010617000-2018-00549
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• 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 Age: 47 YR