MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Failure to Power Up (1476)

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported a complaint that "the autopulse platform (sn (b)(4)) did not power on using the autopulse li-ion batteries" was not confirmed during the functional testing and based on the review of the archive data.The autopulse platform passed the initial functional testing and functioned as intended.The autopulse li-ion batteries (sn (b)(4), (b)(4), and (b)(4)) used during the reported event were received and investigated.No device malfunction was observed, and the batteries functioned as intended.Upon visual inspection, no physical damage was observed.The autopulse platform passed the functional testing without any fault or error.A load cell characterization test was performed and confirmed that both cell modules function within the specification.The autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with several batteries until discharged without any fault or error.A review of the archive data showed no occurrences of the autopulse platform did not power on.The three autopulse li-ion batteries (sn 07095, 07100, and 07152) used around the reported event date powered on the autopulse without any issues, thus not confirming the reported complaint.Further review of the archive data indicated user advisory (ua) 11 (max patient temperature exceeded) error message, unrelated to the reported complaint and was cleared by the user.User advisory is a clearable error message; per the autopulse user advisory list, user advisory 11 is an indication that the temperature of the patient's surface exceeds 45°c (113°f) for more than five minutes (triggers temp sensor near battery bay).The recommended actions for this type of user advisory are: allow the autopulse to cool and perform the post to ensure the device is ready for use.Upon further testing, unrelated to the reported complaint, the autopulse platform failed the brake gap inspection test.The drive train motor brake assembly air gap was too wide (measured at 0.014"), which is out of the specification (0.008") and is not adjustable.The two motor shaft dimples had widened/worn out.The m3-.5 x 4mm set screws would not lock into the encoder shaft's dimple locking wells and caused the brake to disengage.The drive train motor needs to be replaced to address the observed failure.The root cause is likely attributed to the defective component since the drive train motor was replaced in 2018.Zoll is awaiting customer approval for service repair.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, the rescuer should revert to manual cpr, which is the standard of care.In this case, the autopulse platform (s/n (b)(4)) was used to resuscitate patient who was underwater for 30 minutes before the resuscitation attempt.When the crew deployed the autopulse platform for resuscitating the patient, the autopulse platform did not power on using autopulse li-ion batteries.Patient death was reported.After the patient's use, the distributor was unable to duplicate the customer-reported complaint.The autopulse platform and the li-ion batteries used during the patient event were worked as intended.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

The patient was underwater for over 30 minutes before the resuscitation attempt.The crew deployed the autopulse platform (sn (b)(4)) for resuscitating the patient.The customer reported that the autopulse platform did not power on using autopulse li-ion batteries (sn (b)(4), (b)(4), and (b)(4)).Per the customer, the patient died, and the outcome was not related to the autopulse device.The customer provided no further information.After the patient event, the distributor was unable to duplicate the customer-reported complaint.The autopulse platform and the li-ion batteries used during the patient event were worked as intended.Please see the following related mfr report: mfr #3010617000-2021-00874 for the 1st autopulse li-ion battery (sn (b)(4)).Mfr #3010617000-2021-00875 for the 2nd autopulse li-ion battery (sn (b)(4)).Mfr #3010617000-2021-00876 for the 3rd autopulse li-ion battery (sn (b)(4)).

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• 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 thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 12457752
• MDR Text Key: 270997468
• Report Number: 3010617000-2021-00816
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001090
• UDI-Public: 00849111001090
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2021
• 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: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2016
• 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