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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the autopulse platform for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.Medical safety assessments: 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 compressed for about 6 minutes.Manual cpr was performed before autopulse deployment for 4 minutes and after the platform stopped working for approximately 28 minutes.Rosc was not achieved by the combination of mechanical cpr and manual cpr.The transition from autopulse to manual cpr by trained users is quick and similar to the time necessary for rescuer rotation, presenting the same workflow as manual cpr only.Hence, because the conversion to manual cpr is quick and is always available, the patients' outcome is not negatively impacted by the transition when compared to standard of care manual cpr.The cause of patient's death was likely to be patient's underlying clinical condition.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

As reported during a call on (b)(6) 2017, the autopulse platform (sn: (b)(4)) was used on (b)(6) male patient that weighted around (b)(6) that was experiencing cardiac arrest.The crew performed 4 minutes of manual cpr before initiation of the platform.The autopulse platform was deployed and several minutes of compression were performed before the platform stopped working and red fault light came on; however, it did not power off.The platform did not display any error message.The crew then performed manual cpr for approximately 28 minutes.Rosc (return of spontaneous circulation) was not achieved.(b)(6) corner pronounced the patient death.The cause of the cardiac arrest is unknown.Customer does not attribute the patient's death to the use of the autopulse platform.On multiple occasions, the customer had run the autopulse through many scenarios and it never failed to perform compressions in the controlled setting using a manikin.Upon following up for (b)(4) for platform with serial number (b)(4), two additional patient events were reported.(b)(4) were created for the events.This is 2 of 3 events.3010617000-2017-00501 = (b)(4), 3010617000-2017-00568 = (b)(4).

Manufacturer Narrative

The autopulse platform (s/n: (b)(4)) was not returned for evaluation; therefore visual and functional testing was not performed.The customer reported complaint for the autopulse platform stopped working and fail (red) led displayed without any error message was not confirmed during archive review; however; multiple error messages user advisory (ua) 02 (compression tracking error occurred on the first compression), 07 (discrepancy between load1 and load2 too large), 12(lifeband not present) and 18 (max take-up revolutions exceeded occurred during takeup) were noted.Since the platform has not been returned, physical investigation could not be performed.Therefore, a root cause could not be determined the archive data review indicated that on the customer reported event date of (b)(6) 2017 the platform was powered on (duration 22 seconds) and error message ua 18 was displayed.The unit was powered off by the user without any compressions.Eight hours later the platform was powered on and performed 120 compression before displaying an error message ua 07.The unit was power cycled 11 times without cycle of compressions; however, error message ua 07 was not cleared.The platform was also displaying error message ua 02, ua 12 and ua 18 without cycle compression before powered off by the user on the same date.User advisory error messages are designed into the platform when one of several conditions is detected.Ua 07 alerts the user that the load sensing system has detected a weight/load imbalance between the two loads cells might be due to the patient not oriented on the autopulse platform correctly or the patient has shifted during compression or damaged load cell modules.Ua 18 alerts the user that the drive shaft moved the lifeband past the maximum allowable takeup depth without detecting a patient.Ua 02 alerts the user that as the drive shaft rotates and shortens/tightens the lifeband (compresses the chest), the load sensors do not see the expected increase in load.User advisory 12 is an indication that the autopulse has detected that the lifeband is not properly installed.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaints for autopulse sn (b)(4) under ccr 31925 reported on (b)(6) 2017 since the platform was not returned for evaluation, root cause could not be determined.Referenced mfr reports: 3010617000-2017-00501 = ccr 31711 autpulse platform 3010617000-2017-00568 = ccr 31925 autpulse 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 6777846
• MDR Text Key: 82698130
• Report Number: 3010617000-2017-00567
• 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,Followup
• Report Date: 10/31/2017

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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 10/09/2017
• Supplement Dates FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2010
• 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: 73 YR
• Patient Weight: 82