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

Model Number MODEL 100

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

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

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event was not confirmed through functional testing and archive data review of the autopulse platform ((b)(4)).Upon visual inspection, observed cracked front cover, load plate cover defected with the hole that affects the watertight seal.There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.The platform passed the initial functional test without any fault or error.The archive data review showed no error.The platform was tested using the 95% patient test fixture (lrtf) with good known test batteries until discharged and the platform passed without any fault or error.Load cell characterization test confirmed both cell modules are functioning within the specification.A drive train motor brake gap inspection was performed and verified the gap was within the specification.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for the autopulse platform with (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 ((b)(4)) used on a cardiac arrest patient, the life band was broken.Crew reverted to manual cpr immediately.The patient was pronounced dead and the customer didn't attribute the death to using the device.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 ((b)(6) 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.Please see the following related mfr report: mfr # 3010617000-2018-01252 for the lifeband.

Event Description

As reported, while using the autopulse platform (sn 24174) on a patient with cardiac arrest, the life band appeared to be broken.The crew reverted to manual cpr.However, the patient was pronounced dead.According to the crew, the patients death was not related to the autopulse platform.The crew disposed the life band.

Event Description

On january 18, 2019, zoll received a medwatch report (mw5081565) from the fda that the autopulse cpr device paused on the usage of a patient during a code, and after the device was adjusted by personnel.Patient died.

Manufacturer Narrative

Zoll received medwatch report on january 18, 2019.However, the reported event has been investigated and the report has been submitted to fda on december 11, 2018.Submission no: mfr 3010617000-2018-01251.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 8151743
• MDR Text Key: 130078362
• Report Number: 3010617000-2018-01251
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1