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

Model Number	MODEL 100
Medical Device Problem Codes	Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and 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, during the autopulse platform (sn: (b)(4)) was used, it displayed an error message on the screen panel.The crew reposition the patient on multiple occasions and replaced the autopulse li-ion battery but was unable to clear the advisory.Crew immediately performed manual cpr.Also, the belt clip on the lifeband (lot #97059) was broken during patient use.Patient death was reported.The autopulse was 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 or Problem Description
During patient use, customer reported that the autopulse platform (serial #(b)(4)) displayed user advisory - "(ua) 07" (discrepancy between load 1 and load 2 too large) on the screen panel.The crew reposition the patient on multiple occasions and replaced the autopulse li-ion battery but was unable to clear the advisory.Crew immediately performed manual cpr.Also, the belt clip on the lifeband (lot #97059) was broken during patient use.Patient death was reported.The autopulse platform associated with this lifeband is submitted under mfr 3010617000-2020-00640.

• Brand Name: AUTOPULSE LIFEBAND
• Common Device Name: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10228496
• Report Number: 3010617000-2020-00641
• Device Sequence Number: 14251814
• Product Code: DRM
• UDI-Device Identifier: 00849111001588
• UDI-Public: 00849111001588
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2020

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0701-08
• Device Lot Number: 97059
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 07/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1