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

Model Number MODEL 100

Device Problems Loss of Power (1475); Failure to Power Up (1476)

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

Event Date 10/14/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the autopulse platform (sn (b)(4)) for investigation.A supplemental report will be filed when the product 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, when autopulse platform (sn (b)(6)) used on an (b)(6) year old female with cardiopulmonary arrest, it suddenly powered off during active operation state.The customer changed another battery and the platform was powered on successfully.After performing compressions for an unspecified amount of time, the autopulse platform powered off again and the platform wouldn't powered on.The patient was given manual cpr immediately for 30 minutes.However, rosc was not achieved and the patient was pronounced dead at the hospital.The autopulse was intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the 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.A cardiopulmonary arrest (or circulatory arrest) is also called a cardiac arrest and indicates a sudden stop in effective and normal blood circulation due to failure of the heart to pump blood.In this event, death is attributed to out-of-hospital cardiopulmonary arrest.Death is an expected outcome for out-of-hospital cardiopulmonary arrest.Please see the following related mfr report: mfr # 3010617000-2018-01144 the 1st autopulse li-ion battery.Mfr # 3010617000-2018-01145 the 2nd autopulse li-ion battery.

Event Description

As reported, the autopulse platform (sn (b)(4)) was used to treat an (b)(6) year old female patient with cardiopulmonary arrest.The platform performed compressions for a while and suddenly powered off.The customer changed the battery and the platform was powered on successfully.After performing compressions for an unspecified amount of time, the autopulse platform powered off again and the platform wouldn't power on.The patient was given manual cpr for 30 minutes.However, rosc was not achieved and the patient was pronounced dead at the hospital.

Manufacturer Narrative

There were no device deficiencies found during evaluation of the returned autopulse platform (sn (b)(4) that could have caused or contributed to the reported complaint.The autopulse platform performed as intended.Upon visual inspection, observed sticky shaft and noticed slightly bent battery clip on the platform, unrelated to the reported complaint.During initial functional testing, the autopulse platform made an abnormal noise when the platform started running.The archive data review showed occurrence of multiple user advisory (ua) error messages occurred on 10/16/2018, rather than on the reported event date given by the customer of (b)(6) 2018.On (b)(6) 2018, the autopulse was powered on and performed compressions for 47 minutes.Three different autopulse li-ion batteries (sn (b)(6) and sn (b)(6) were used during these compressions.Li-ion battery s/n (b)(6) performed 313 compressions for 5 min until the platform displayed warning 1 - low battery warning followed by user advisory 17 - max motor on time exceeded followed by user advisory 2 - compression tracking error occurred on the first compression (this typically occurs if the patient is misaligned on the platform or the lifeband is opened).This cycle compression occurred 11 times at approximately each 2 minutes interval.Then the user changed out battery s/n (b)(6) and replaced it with a fully charged li-ion battery s/n (b)(6).Upon changing out the battery, the platform displayed user advisory 45 - shaft not at "home" position occurred (the lifeband straps were not pulled completely out prior to turning the device on).The user cleared the ua45 within one minutes and continued compression.The platform continued to perform compression for over 6 minutes time period with the platform displayed ua17 error messages three times and ua2 error messages four times within this period.Then the user changed out battery s/n (b)(6) and replaced it with a fully charged li-ion battery s/n (b)(6).The user cleared ua17 error messages within 30 seconds and continued compression.The platform continued to perform compression for over one minute time period with the platform displayed ua17 error message and ua2 error messages three times within this period.Then the user changed out battery s/n (b)(6) and replaced it with a fully charged li-ion battery s/n (b)(6).Upon changing out the battery, the platform displayed ua45 error message and the user cleared the ua45 error within 30 seconds and continued compression for over 7 minutes time period with the platform displayed ua17 nine times and ua2 three times within this period.Then the user stopped using the autopulse platform.Six and half hours later on the same day (10/16/2018), the platform was used again for compression using li-ion battery s/n (b)(6) (not fully charged, 3 bars).The platform performed 457 compressions for 20 minutes with no errors noted.User advisory is a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.User advisory 2 is an indication that the autopulse® has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.The recommended actions to take for this type of user advisory are: ensure that the lifeband is properly closed.Pull up completely on the lifeband, ensure that both the patient and the band are properly aligned, and press restart.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.Per the autopulse® resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory (45) pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with serial number (b)(6).Please see the following related mfr report: mfr # 3010617000-2018-01144 for the 1st autopulse li-ion battery mfr # 3010617000-2018-01145 for the 2nd autopulse li-ion battery mfr # 3010617000-2018-01146 for the 3rd autopulse li-ion battery.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 8053837
• MDR Text Key: 126684547
• Report Number: 3010617000-2018-01139
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

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
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 11/18/2018
• Supplement Dates FDA Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR