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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

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

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the zoll platform in complaint for investigation.A supplemental report will be filed when the investigation has been completed.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 was used in a cardiac arrest patient who was found pulseless unwitnessed, the crew immediately implemented manual cpr when the platform stopped performing compressions after 8 minutes due to ruptured lifeband on the left side.Return of spontaneous circulation (rosc) was not achieved and the patient was pronounced.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 ((b)(6) circulation, 2016).Death is an expected outcome for ohca.

Event Description

As reported, the crew arrived on the scene in response to a (b)(6) years old patient (estimated weight at (b)(6) kg) in cardiac arrest.The cardiac arrest was unwitnessed and the patient was found pulseless.The patient had a history of diabetes and had undergone coronary artery bypass surgery two times.Prior to the cardiac arrest, the patient experienced a shortness of breath and altered level of consciousness.The platform displayed multiple times "realign patient" message.The crew performed troubleshooting by realigning the patient on the platform each time.No other messages were noted by the crew.The platform stopped performing compressions after 8 minutes due to ruptured lifeband on the left side near the patient's midaxillary line.The crew immediately performed a manual cpr for 5 minutes, however, the return of spontaneous circulation (rosc) was not achieved and the patient was pronounced by the crew, followed online medical direction.Per the reporter, the patient's death was not related to the device.The lifeband was disposed of by the customer and not returning for evaluation.In addition, the user observed the fan malfunction on the autopulse platform, however, no further information was provided.

Manufacturer Narrative

The customer reported complaint for the platform stopped compressions was confirmed during archive data review but not during functional testing.In addition, unable to duplicate fan malfunction reported by a customer.There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.No lifeband was returned with this device.However, a picture was provided.From the twist in the band, it appears the lifeband was inadvertently installed incorrectly.The autopulse passed the initial functional test without any fault or error.Visual inspection was performed and found a damage front enclosure, unrelated to the reported issue.To remedy the issue, the front enclosure was replaced.Review of the archive data indicated multiple user advisory (ua) 19 (time out moving to take up position) and user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error messages occurred on the reported event date.User advisory is the clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.The user advisory (ua) 19 alerts the operator that the load plate has detected too much weight being applied.This user advisory will persist until the restart button is pressed and the autopulse platform is restarted.The user advisory (ua) 07 error message alerts the operator that the load sensing system has detected a weight/load imbalance between the two load cells.(ua) 07 indicated that either the patient not oriented on the autopulse platform correctly or the patient has shifted during compression.The load cell characterization test confirmed both load cell modules are functioning within the specification.The platform was further tested with large resuscitation testing fixture, (lrtf) equivalent to 250-pound patient for 15 minutes and passed all functional testing criteria and met all required specifications.Historical complaints were reviewed for information related to the reported complaint and there was no previous history of complaint reported for the autopulse platform with sn (b)(4).

• 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: 8241163
• MDR Text Key: 133130054
• Report Number: 3010617000-2019-00026
• 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: 01/30/2019

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: 01/10/2019
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 120