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

Model Number MODEL 100

Device Problem Power Problem (3010)

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

Event Date 06/20/2022

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(4) was shutting off after about 10 seconds or unable to power on completely" was not confirmed during functional test or archive data review.No device malfunction was observed during the functional testing and the autopulse platform performed as intended.The probable root cause of the reported complaint could not be conclusively determined.However, the power distribution board was replaced as a preventive precautionary measure to help prevent reoccurrence.Upon visual inspection, the front enclosure was cracked, unrelated to the reported complaint.The probable root cause for the observed physical damage was user mishandling.The front enclosure was replaced to address the damage.The archive data review indicated multiple (ua)17 (motor on for too long during active operation), unrelated to the reported complaint.The brake gap was verified to be within specification.Per the battery hangtag - advisory codes description and action, user advisory 17 is an indication that the lifeband is twisted, or battery voltage is low.The recommended actions to take for this type of user advisory are: open lifeband, start manual cpr, check battery and lifeband, pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.The autopulse platform passed the initial functional test without any fault or error and the reported complaint and (ua) 17 seen in the archive could not be reproduced.No damaged wires or loose grounds could be found.Nevertheless, the power distribution board was replaced as a preventive precautionary measure, as there may have had some intermittent technical problems that could not be directly identified during the functional testing.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The autopulse platform passed the final testing without any fault or error.The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr, adjunctive use only indication is prominently displayed on device labels and in the device manual.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions when effective manual cpr is not possible.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 (sn 37007) was shutting off after about 10 seconds and unable to power on completely during the patient use.Manual cpr was performed.It was unknown if the return of spontaneous circulation (rosc) was achieved or not during the resuscitation.It's reported that the patient passed away but the death was likely due to the condition of the patient and not the device.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

During patient use, the customer reported the autopulse platform (sn (b)(4) was shutting off after about 10 seconds or unable to power on completely.The platform was tested with 3 different autopulse li-ion batteries (sn unknown).Two batteries were only able to power on the platform for 10 seconds.The other battery was unable to power on the platform at all.The status leds on all three batteries showed 4 solid green lights.Manual cpr was performed.When back at the station, the platform was unable to be powered on using the inserted batteries after being inside for 15 minutes.The batteries were pulled from the platform and exchanged with new batteries and the platform powered on immediately when the power button was pressed.It was noticed that the batteries that were pulled from the platform were very warm.While troubleshooting with the customer over the phone, the three batteries were retested and the batteries performed as intended.Two days later, the customer reported the autopulse platform was indoors all shift but it was unable to power on.The battery had been left in the platform for 12 hours but was fully charged and showing 4 solid green lights on the status leds before it was inserted into the platform.When they took the battery out of the platform, they noticed the battery was very warm and was only showing 3 bars on the battery's led status bar.On (b)(6) 2022, the customer reported that the platform is performing as intended.Upon follow up, the customer reported the patient passed away but that the death was likely due to the condition of the patient and not the device.Please see the following related mfr report: mfr # (b)(4) for the autopulse li-ion battery (sn unknown).Mfr # (b)(4) for the autopulse li-ion battery (sn unknown).Mfr # (b)(4) for the autopulse li-ion battery (sn unknown).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15071262
• MDR Text Key: 297420136
• Report Number: 3010617000-2022-00974
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• 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: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death