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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the product for evaluation, however, investigation is pending.A supplemental report will be filed when the investigation has been completed.

Event Description

During a (b)(6) year old female patient use in cardiac arrest, customer reported that the autopulse platform (serial #: (b)(4)) functioned properly for ten minutes and then displayed a user advisory - ua45 (not at "home" position after power-on/restart) error message.The crew replaced the lifeband to try and clear the error but the platform still did not function properly.The crew reverted to manual cpr and performed for 10 minutes.The crew reported that the patient expired.After returning to the station, the crew again replaced the lifeband but the platform this time displayed a ua12 (lifeband not present) error message.Zoll has learned that the patient expired on (b)(6) 2018, 5 days after the clinical used of the platform.Therefore, zoll determined that rosc was achieved prior to patient death and the autopulse platform was not related to the patient's outcome.

Manufacturer Narrative

The reported complaint of user advisory - ua45 (not at "home" position after power-on/restart) and ua12 (lifeband not present) error messages on the autopulse platform (serial #(b)(4)) were confirmed during functional testing and during archive data review.The investigation findings revealed that the root cause of ua45 was due to the driveshaft not to be at home position and the root cause of ua12 was due to two loose screws that holds the lever parallel to the belt clip switch.Per the autopulse resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on, a user advisory - ua45 will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory - ua45, pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.No physical damage observed on the ap platform during visual inspection.During archive data review, ua45 and ua12 error messages were identified on the date event.Thus, confirming the reported complaints.To remedy ua45, the drive shaft was returned to home position using the administrative menu and to remedy ua12, the belt clip switch was adjusted and tighten the two lock screws that holds the switch lever parallel to the switch case.After all faults were fixed, the autopulse platform was tested and passed all functional tests.The ap platform is ready for clinical use.Historical complaints were 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).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, when the autopulse platform (sn (b)(4)) was used in a cardiac arrest patient, it stopped compressions after ten minutes worked properly.The crew reverted to manual cpr at that point, however, the patient expired on (b)(6) 2018, 5 days after the clinical used of the 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.Out-of-hospital cardiac arrest (ohca) is one of the main causes of death in industrial nations.About 25% of patients survive this event and make it to the hospital, and even fewer patients survive after 24 hours (nichol, nejm, 2015).In the united states, survival to hospital discharge after non-traumatic emergency medical services-treated cardiac arrest with any first recorded rhythm was 10.6% for patients of any age.Of the bystander-witnessed out-of-hospital cardiac arrests in 2011, 31.4% of victims survived to hospital discharge (mozaffarian, circulation, 2016).Death is an expected outcome for ohca.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8200546
• MDR Text Key: 131589092
• Report Number: 3010617000-2018-01262
• 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: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• 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: 12/18/2018
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR