MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; 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 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the zoll platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

The autopulse platform ((b)(4)) was used on the (b)(6) year-old male patient (estimated at (b)(6) lb) in cardiac arrest.There were no signs of trauma reported.Patient's medical history included: hypertension and kidney problems.The patient was prescribed the amlodipine.Upon deployment, the autopulse platform displayed error message user advisory (ua) 18 (max take-up revolutions exceeded).The customer attempted to troubleshoot the reported problem by readjusting the lifeband and restarting the platform without any success.The patient was removed from the platform and the crew immediately implemented manual cpr, which was performed continuously throughout the transport time to the hospital.The patient was left with ongoing resuscitation at the emergency room.The return of spontaneous circulation (rosc) was not achieved and the patient was pronounced later in the hospital; however, the cause of death was not specified.According to the reporter, the patient outcome was not attributed to the device.Additional information was provided by the user, who believes that the reported user advisory (ua) 18 error was due to the size of the patient.It was indicated that the platform was further tested and the user was not able to reproduce the (ua) 18 error message.The platform was functionally tested and operated on a mannequin during multiple tests.No further issue was observed.

Manufacturer Narrative

The customer's reported complaint of the autopulse platform displayed user advisory (ua) 18 (max take-up revolutions exceeded) error message was confirmed during the archived review, but not during the initial functional testing.There were no device deficiencies found during evaluation of the returned console that could have caused or contributed to the reported complaint.The autopulse passed the initial functional testing.In addition, load characterization check was performed and verified that the load cells are within specification.As part of routine service during testing, the platform was examined and unrelated to the reported complaint, the front cover was found cracked/damaged and the encoder drive shaft does not rotate smoothly, exhibits binding and resistance.The sticky clutch plate was deburred and the front cover was replaced to address the issue.The autopulse platform is a reusable device and was manufactured in 2011 and is 7 years old.It has exceeded its expected service life of 5 years.This type of physical damage found during visual inspection is characteristic of normal wear and tear for the age of the device.Review of the archive data indicated user advisory (ua) 18 errors occurred on the reported event date, thus confirming customer complaint.Possible root cause could be due to the size of the patient's chest (too small) or the weight of the patient placed on the platform is too light.Note that user advisory error messages are designed into the platform when one of several conditions is detected.User advisory (ua) 18 is an indication that the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.If the user advisory does not clear, the patient may be too small.The platform was further tested using the manikin with lrtf (large resuscitation test fixture) with continuous compressions with a good known test battery until discharged and passed with no issue or faults observed.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse platform sn (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 31766) was used in a cardiac arrest patient, it displayed error message upon deployment.The patient was removed from the platform and the crew immediately implemented manual cpr which was performed continuously through the transport time to the hospital.Return of spontaneous circulation (rosc) was not achieved and the patient was pronounced later in the hospital.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® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8220211
• MDR Text Key: 132393936
• Report Number: 3010617000-2019-00014
• 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: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• 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: 01/10/2019
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 50