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

Model Number MODEL 100

Device Problems Failure to Sense (1559); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform was returned to zoll on 07/19/2017 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.Referenced mfr reports: mfr 3010617000-2017-00626 = (b)(6) autopulse platform, mfr 3010617000-2017-00628 = (b)(6) autopulse platform, mfr 3010617000-2017-00640 = (b)(6) autopulse platform, mfr 3010617000-2017-00636 = (b)(6) li-ion battery, mfr 3010617000-2017-00620 = (b)(6) li-ion battery, mfr 3010617000-2017-00638 = (b)(6) li-ion battery, mfr 3010617000-2017-00637 = (b)(6) li-ion battery, mfr 3010617000-2017-00621 = (b)(6) li-ion battery, mfr 3010617000-2017-00639 = (b)(6) li-ion battery, mfr 3010617000-2017-00633 = (b)(6) li-ion battery, mfr 3010617000-2017-00622 = (b)(6) li-ion battery.

Event Description

The customer reported 4 separate events involving possibly three (3) autopulse platforms and eight (8) li-ion batteries.The specific autopulse platform and li-ion batteries that were used at the time of the event is not known.Event 1: per patient care report (pcr), (b)(4) received a 911 call for a (b)(4) male patient weighing (b)(6) who was found on the ground experiencing cardiac arrest.Manual cpr was initiated by the family member with no respiratory effort.The patient was extracted and moved to the ground by the crew then cpr was initiated and aed was placed.The patient was transferred to a backboard and aed shock was administered and then cpr was resumed.The patient was reported to have an unspecified cardiac and respiratory problem that required supplemental oxygen via nasal cannula (nc).During treatment, the autopulse platform powered off after only performing 10 minutes of compressions.The customer then replaced the battery with another fully charged battery; however, the platform again only performed 10 minutes of compression before powering off.The customer then reverted to manual cpr until they reached to (b)(6) hospital.The patient was pronounced dead by the er physician.

Manufacturer Narrative

The autopulse platform (sn: 33465) was returned to zoll for evaluation.During the visual inspection no physical damage was noted.However, the encoder drive shaft exhibited some binding and resistance to rotation during visual and physical inspection.A review of the archive files showed one "timed out" and a few "battery lost" events recorded in june and january."timed out" is when the device powers itself off if no button is pressed for 10 minutes."battery lost" is when the battery is removed from the autopulse while the device is powered on.This could have occurred during training or routine device checks but does not appear to have occurred during a clinical deployment.No other discrepancies were noted.The battery (s/n (b)(4)) was the only battery used in this platform (s/n 33465) and performed without any issue noted in the archive.The autopulse passed functional testing without any issues.This testing was performed with a large resuscitation test fixture (large rtf) using customer's returned batteries (s/n's (b)(4)) until fully discharged without any faults or errors.The large rtf is an instrumented manikin that replicates the 95th percentile of human chest dynamics as it relates to size and stiffness based on published anthropomorphic studies.The large rtf has 150 pounds/inch springs, with the autopulse compressing to the specification depth of 1.85 inches.The run time for the batteries during this test ranged from 39 to 50 minutes, which is well within normal expected operating range.Additional maintenance and inspections were completed (unrelated to the reported complaint) to ensure that the autopulse will continue to function properly, including deburring the clutch plate, load cell characterization and brake gap inspection.After all work was completed, the autopulse was assessed again to ensure it met all specifications and passed all functional testing.There was nothing found during evaluation of autopulse s/n 33656 which could have caused or contributed to the reported complaint.The autopulse functioned as intended.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for autopulse sn (b)(4).Medical safety assessment: 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, manual cpr was initiated by the family member and then performed by ems crew before the deployment of autopulse.The autopulse performed 10 minutes of compressions and stopped.The customer then replaced battery.The platform again performed 10 minutes of compression and then powered off.The customer then reverted to manual cpr until they reached the hospital.Rosc was not achieved after a combination of manual and mechanical cpr.For a trained user, changing battery or changing from the autopulse to manual cpr can be made quickly, and is similar to the time necessary for rescuer rotation, presenting the same workflow as high quality manual cpr.Because the changing of battery, and conversion from mechanical to manual cpr were quick and available, the patients' outcome was not negatively impacted when compared to standard of care manual cpr.The cause of patient's death was likely to be patient's underlying clinical condition.Mortality of out-of-hospital cardiac arrest (ohca) is high.Survival to hospital discharge, after ems-treated non-traumatic cardiac arrest with any first recorded rhythm was 9.8% for adults (aha statistical update 2013).Death is an expected outcome for ohca.

Event Description

9 li-ion battries.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 6778469
• MDR Text Key: 82989279
• Report Number: 3010617000-2017-00599
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• 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?: Yes
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2016
• 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
• Patient Age: 74 YR
• Patient Weight: 130