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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform was returned to zoll on 21 march 2017, for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.No information was reported regarding the patient's clinical condition.It is not known if the gi bleeding was a pre-existing condition before the deployment of the autopulse device.Lifeband compresses on the patient's chest.Patient shall be aligned with armpits to the yellow line on the platform.Chest bands shall be maintained at 90 degrees to platform and free of obstructions.Based on available information, the temporal and spatial characteristics of the event indicates no relationship to the use of the autopulse device.The death was not related to the device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.If the autopulse does not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.Based on available information, the autopulse provided approximately 2-3 compressions then stopped.Compression was quickly restarted by pulling up the lifeband.It is not clear how long the platform compressed and then the attending nurse aborted the platform.It was not clear if manual cpr was performed.The short interruption of trouble shooting by pulling up the lifeband is unlikely to negatively impact the patient outcome.

Event Description

On an unspecified date, the autopulse platform (s/n: (b)(4)) was used on a patient.It was reported that the platform provided approximately 2-3 compressions then stopped.According to the reporter, the lifeband was pulled up and platform was restarted.It is not clear if the platform stopped compression again, as the attending nurse aborted the platform quickly.It was noted that the patient had extensive gi bleeding with a large abdomen.The patient expired a short time later.No further information was provided.

Manufacturer Narrative

The primary complaint that the autopulse provided 2-3 compressions then automatically stopped, was not confirmed.According to the archive data, there were no such events recorded on or prior (b)(6) 2017 (the presumed event date).Since the customer's complaint could not be replicated a root cause of the issue could not be determined.Review of the archive data, revealed that on (b)(6) 2017, the autopulse stopped compression with a user advisory (ua) 7 error message.Ua 7 can occurred when the load sensing system detects a weight/load imbalance between the two load cells, when the patient is not oriented on the autopulse platform correctly, or when the patient has shifted during compression.A ua 2 was also recorded on the first compressions improper take up.As the drive shaft rotates and shortens/tightens the lifeband (compresses the chest), the load sensors do not see the expected increase in load.False take-up, possible movement of patient or board.During functional testing, a ua 16 error message occurred (unrelated to the complaint and to recorded advisories).Further evaluation found the drive train motor was defective.To prevent the reoccurrence of ua 16, the drive train motor was replaced.A load cell characterization test also confirmed that both load cell modules are functioning within the specification.The autopulse platform is a reusable device and was manufactured in 2016.Device history record was reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).The platform passed all final testing criteria.Case#1 (b)(4) mfr 3010617000-2017-00260, case#2 (b)(4) mfr 3010617000-2017-00263, case#3 (b)(4) mfr 3010617000-2017-00277.

Event Description

In a follow-up with the reporter, it was clarified that an rn witnessed the (b)(6) male in cardiac arrest while in the icu.The hospital's code team was contacted as the rn performed cpr.According to the reporter, there was an unspecified issue upon deploying the platform.It is not known if a user advisory message appeared after the platform was powered on.The platform did not provide compressions and was aborted.Per reporter, the rn believed the platform did not work due to the patient's massive abdomen as a result of patient's gi bleed.No autopsy report was provided.No further information was given.The customer reported 4 separate events regarding the autopulse platform with serial number (b)(4).The date when each of the events took place however, is not known.This is case #4 of 4.

Manufacturer Narrative

The device history record was reviewed.The platform manufactured on august 2016 met all manufacturing testing and inspection requirements and specifications when it was initially shipped to the customer.There was no device nonconformance which could have attributed to this event.This autopulse platform was implemented at the customer's site in (b)(6) 2017 and has not been the subject of a complaint before this one.The customer's report that the platform did not provide compressions.However, this could not be confirmed due to the unknown event date.During the archive review, a number of user advisories were noted.Per customer, the autopulse platform was rolled out to use around second week of (b)(6) 2017.The autopulse platform load cells were evaluated as part of the investigation.The load cells of the autopulse platform were functioning normally.No other defects were found that could have contributed to the reported event.The autopulse performed as intended and improper use of the autopulse may have contributed to the reported event.Visual inspection of the platform (s/n (b)(4)) identified that the load plate cover was damaged.The damage is consistent with dropping the platform and is not related to the cause of the customer's reported event.The damage appears to have been caused by mishandling of the autopulse platform.Since the event date was unknown and the customer reported the complaint on (b)(6) 2017, therefore a review of the autopulse's archive was performed from (b)(6) 2017 to (b)(6) 2017.The archive data shows multiple user advisories messages were exhibited between (b)(6) and (b)(6) of 2017.They are ua18 (max take-up revolutions exceeded), ua45 (shaft not at "home" position), ua20 (position out of range), ua7 (discrepancy between load1 and load2 too large), ua2 (compression tracking error), ua12 (lifeband not present), ua17 (max motor on time exceeded), warning 1 -low battery warning, and ua4 (battery charge state too low).User advisory 7 message is exhibited if the patient is incorrectly aligned on the autopulse platform laterally (patient is positioned too far to the patient's left or right side).The intent of the user advisory 7 message is to make the user aware that the patient needs to be aligned to the correct position on the autopulse platform prior to initiating compressions.The ua7 stops chest compressions to prevent patient injury that could occur if the patient is placed too far to the patient's left or right side on the platform.Measuring patient location laterally, stopping compressions and displaying a ua7 is a normal safety function of the product.User advisory 12 message is exhibited when the autopulse does not detect that a lifeband is attached to the autopulse platform when the platform is powered on.This ua12 is normally displayed when the user is replacing the single use disposable lifeband after each patient treatment.In this case, ua12 happened during patient care.The autopulse archive review showed a ua12 message was exhibited after the patient was placed on the platform and after the first realign message.Absence of hardware failure indicates that the patient might have been removed from the platform to re-install the lifeband.User advisory 2 fault is raised when the drive shaft rotates and tightens the lifeband (to compress the chest), the load cells do not see the expected increase in load, typically when there is no patient on the autopulse platform or the patient is not placed correctly.The user advisory 2 is also raised if the lifeband is opened during active operation.User advisory 18 is an indication that the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform or the lifeband is open during take-up.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.User advisory 20 fault was due to the encoder drive shaft not being within the normally acceptable range of positions.Typically, if the ua 45 is not resolved properly, it leads to ua 20 because the drive staff is not restored at the home position.User advisory 17 is raised when the autopulse cannot provide enough power for compressions.Typical scenarios include a twisted lifeband and or low battery voltage that occurs when battery is not fully charged.If the battery is not replaced to mitigate the low battery warning, it leads to ua4 indicating a depleted battery.The load cells of the autopulse platform were evaluated.A load cell measures a combination of the patient torso weight and the force applied by the lifeband during compression.The results of the load cell characterization test indicated that both load cell modules were functioning within specification and did not exhibit any issues.This narrows down the root cause to improper alignment of the patient on the autopulse platform.Functional testing was performed with the run-in test using a 95% patient test fixture (large resuscitation test fixture).No device defect or malfunction was found related to the reported complaint.Unrelated to the reported complaint, user advisory 16 (timeout during take-up) was observed.This ua was not reported by the customer, and was not found in the autopulse archive.To remedy the ua 16, the drivetrain assembly was replaced.Based on the investigation, there were no parts identified for replacement that were related to the customer complaint.The autopulse platform functioned as intended.

• 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: 6447059
• MDR Text Key: 71333396
• Report Number: 3010617000-2017-00254
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2017

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: 8700-0700-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 03/30/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/26/2017; 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2016
• 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