MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE LIFEBAND; CARDIAC RESUSCITATOR BAND

Model Number MODEL 100

Device Problems Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/05/2021

Event Type  malfunction  

Manufacturer Narrative

The autopulse lifeband involved in the reported complaint will not be returned for evaluation because the customer has disposed of it.Therefore, a physical investigation could not be performed, and the root cause could not be determined.According to available information, 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.The autopulse is intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the trained 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.

Event Description

An autopulse platform #1 (sn unknown) was deployed by the ems team #1 for resuscitating a (b)(6) years old male patient ((b)(6)kg) in cardiac arrest caused by persistent ventricular fibrillation.There were no signs or symptoms of trauma observed.The cardiac arrest was witnessed.The manual cpr was performed by the bystander for an unknown period.The basic life support started 5-8 minutes after the collapse and advance life support was started 10 min after the collapse.The customer reported that the new material of the autopulse lifeband (lot # unknown) is too soft, causing the lifeband to be more likely twisted around itself, on the autopulse edges, while trying to be installed on the autopulse platform.This issue causes the autopulse driveshaft to get stuck upon turning on.The autopulse platform fails to size the patient.The customer tried to pull up the lifeband, however, the issue persisted.The ems team #1 continued performing the manual cpr until the arrival of ems team #2.The ems team #2 deployed the autopulse platform #2 (sn unknown), however, the same issue persisted.The ems team continue performing the manual cpr for 38 minutes until the patient was transferred to the hospital.At the hospital, the patient was placed on the autopulse platform #3 (sn unknown) and the same issue persisted.The manual cpr was continued, however, the return of spontaneous circulation (rosc) was not achieved, and the patient was pronounced dead.The customer did not provide information regarding the relationship between the death and the alleged malfunction.However, the msa evaluate the incident and it was determined that the death was not related to the autopulse device.The customer replaced the lifeband, and the issue was resolved.Per the customer, the autopulse platforms are working as intended.Please see the following related mfr reports: mfr 3010617000-2021-00977 for autopulse platform #1.Mfr 3010617000-2021-00970 for autopulse lifeband used with autopulse platform #1.Mfr 3010617000-2021-00978 for autopulse platform #2.Mfr 3010617000-2021-00979 for autopulse platform #3.Mfr 3010617000-2021-00981 for autopulse lifeband used with autopulse platform #3.

• Brand Name: AUTOPULSE LIFEBAND
• Type of Device: CARDIAC RESUSCITATOR BAND
• 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: kim nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 12621025
• MDR Text Key: 277936774
• Report Number: 3010617000-2021-00980
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001601
• UDI-Public: 00849111001601
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• 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: 8700-0701-16
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 95