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

Model Number MODEL 100

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abrasion (1689); Burn(s) (1757); Cardiac Arrest (1762); Death (1802); Fall (1848); Loss of consciousness (2418)

Event Date 05/31/2015

Event Type  Injury  

Event Description

An initial call came in at 10:30 am on (b)(6) 2015 for a (b)(6) year old female patient weighing (b)(6) in cardiac arrest.Patient had no medical history or allergies and was not taking any medications.The arrest occurred at the patient's home and was unwitnessed.Patient's husband heard her fall and went upstairs to check on her.Patient was found unresponsive in the bathroom floor.A family member initiated manual cpr for approximately 12 minutes.The police department and fire department arrived on scene and took over manual cpr (exact length of time was not provided).Ems crew arrived on scene at 10:42 am.The autopulse platform was deployed within a minute of arrival.There were no issues with deployment of the platform.Ems crew also connected a monitor directly to the patient.The platform performed compressions for about 27 minutes.Patient was extricated via backboard down the stairs and into the ambulance.Ems crew left scene at 11:10 am.The autopulse was paused in the ambulance for a rhythm check.The monitor indicated that the patient was in a shockable rhythm so the patient was defibrillated at 11:14 am.Patient's rhythm then became non-shockable.The crew restarted the autopulse platform but felt that autopulse compressions were weak.They replaced the battery but still felt that compressions were not fast and deep enough.Use of the autopulse was discontinued and the crew reverted to manual cpr until they arrived at the hospital at 11:27 am.When the patient was taken off of the autopulse, the crew noticed abrasions on the right lateral side of the patient's chest.Ems manager indicated that there were no cuts and that the abrasions looked like a rug burn.No treatment was provided for the abrasions.It is unknown what the course of treatment in the er was.Return of spontaneous circulation (rosc) was never achieved.Patient was pronounced dead by the physician, a few minutes after arrival at the hospital.Ems manager indicated that the chest abrasions were related to the autopulse because there were no signs or symptoms of trauma prior to use of the autopulse.However, he did not attribute the abrasions or the autopulse to the patient's death.It is unknown if an autopsy was performed.The cause of the cardiac arrest is also unknown.Ems manager indicated that the cause of death was cardiac arrest.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 06/08/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform are as follows: visual inspection of the returned platform was performed and found holes on the load plate cover.From the condition of the platform, the damage appears to have been caused by user handling (autopulse manufactured in may of 2014).The physical damage found during visual inspection is unrelated to the customer's reported complaint that autopulse compressions were weak after restarting the device.A review of the platform's archive data was performed and found multiple occurrences of user advisory (ua) 17 (max motor on time exceeded during active operation), ua 2 (compression tracking error), warning 1 (low battery warning) and ua 4 (battery charge state too low (replace battery)) on the reported event date of (b)(6) 2015.Based on the archive data, li-ion battery with serial number (sn) (b)(4) was used on a small/medium patient.This battery was fully charged and had a high remaining capacity (rc) of 1258 when compressions were first initiated.After more than 2000 cycle compressions, the battery's rc dropped down to 831 as intended.The platform continued to provide compressions but stopped twice after a few seconds due to a user advisory (ua) 17 (max motor on time exceeded during active operation).The platform was then restarted again but stopped a few minutes later with a ua 2 (compression tracking error).The archive data indicated that this occurred multiple times.The platform continued to be used as the rc of the same battery dropped to 495.A "low battery" warning message followed by ua 4 (battery charge state too low (replace battery)) messages then displayed as intended to warn the user that the battery's charge has fallen too low and that the battery should be replaced.The archive data does not show any activity after the "low battery" warning message and the ua 4 messages, which indicates that the customer did not replace the battery as was initially reported.A review of the platform's archive data was performed to assess the customer's battery management.Li-ion battery with sn (b)(4) was manufactured in may of 2014.Based on this date, this battery is within its expected lifetime of 3 years from its date of manufacture.Per the autopulse battery management program, a battery should be test cycled on a monthly basis.The number of test cycles obtained for this battery was 9 cycles.If proper battery management was being followed, the expected number of test cycles would be 13.Not following the recommended battery maintenance program may result in faster aging.Review of the platform's archive data did not reveal any issues related to the reported complaint.The reported complaint was not duplicated during functional testing of the returned platform.A run-in test was performed using a 95% patient test fixture for several hours without any issues.A brake gap inspection was performed, which verified that the brake gap was within specification of 0.008" ±0.001".A load cell characterization test was also performed, which verified that both load cells were functioning within specification.Based on the investigation, the part identified for replacement was the load plate cover.In summary, the customer's reported complaint that autopulse compressions were weak after restarting the device was not confirmed.Review of the platform's archive data found several ua 17, ua 2, "low battery" warning and ua 4 messages on the reported event date.The archive data indicates that the "low battery" warning and ua 4 messages displayed as intended to warn the user to replace the battery.However, the archive data does not show any activity after the "low battery" warning message and the ua 4 messages, which indicates that the customer did not replace the battery as was initially reported.Per the autopulse maintenance guide, a ua 2 can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation and a ua 17 can occur due to a twisted lifeband or a low voltage battery.It should be noted that no batteries were returned for evaluation.Review of the platform's archive data did not reveal any issues related to the reported complaint.There were no device deficiencies found during evaluation of the returned platform which could have caused or contributed to the reported complaint.A run-in test was performed using a 95% patient test fixture for several hours without any issues.A brake gap inspection was performed, which verified that the brake gap was within specification of 0.008" ±0.001".A load cell characterization test was also performed, which verified that both load cells were functioning within specification.The physical damage found during visual inspection is unrelated to the reported complaint and appeared to have been caused by user handling.After replacement of the load plate cover, the platform successfully passed all final functional testing.There were also no device deficiencies found during evaluation of the returned platform which could have caused or contributed to the reported abrasions and patient death.Ems manager indicated that the cause of death was cardiac arrest.He did not attribute the abrasions or the autopulse to the patient's death.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4872759
• MDR Text Key: 6261968
• Report Number: 3010617000-2015-00367
• Device Sequence Number: 1
• Product Code: DRM
• 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,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 06/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2014
• 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
• Treatment: X-SERIES MONITOR
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 100