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 05/20/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event was confirmed through functional testing and archive data review of the autopulse platform (sn (b)(4)).The root cause is due to a defective load cell.Evaluation of the platform during initial power up, revealed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error message on the user control panel.The archive data was reviewed and contained multiple ua 7 error message on the (b)(6) 2018 confirming the reported event.A load characterization check was performed and identified a defective load cell.As part of routine service during testing, the platform was examined and found physical damage on the top cover and the drive shaft exhibits binding and resistance.This observation is unrelated to the reported event.After replacement of the load cell and the damaged top cover and clutch plate deburring, the platform was functionally tested and operated as intended.The platform passed all testing specifications with no further issue observed.Historical complaints were reviewed for service information related to the reported complaint and there were two similar complaints reported for autopulse with serial number (b)(4).(b)(), reported on (b)(6) 2015.(b)(4), reported on (b)(6) 2017.The load cells were replaced to remedy on both complaints.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 user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error message upon deployment, the user was unable to clear the ua 7 error message.The crew immediately performed manual cpr for approximately 25 minutes.The patient was pronounced at the scene.The cause of cardiac arrest was unknown.The customer does not attribute the patient's death to the autopulse platform.No compression was provided by 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.Autopulse did not provide compressions, and did not cause or contribute to the patient's death.In this event, death is attributed to out-of-hospital cardiac arrest (ohca).Death is an expected outcome for ohca.

Event Description

Upon deployment, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error message, the user was unable to clear the ua 7 error message.The crew immediately performed manual cpr for approximately 25 minutes.The patient was pronounced at the scene.The cause of cardiac arrest was unknown.The customer does not attribute the patient's death to the autopulse platform.

• 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: 7617407
• MDR Text Key: 112294487
• Report Number: 3010617000-2018-00590
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: 06/19/2018

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2015
• 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