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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); 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

Since the customer could not specify the user advisory (ua) error message at the time of the event, the primary complaint could not be confirmed.During visual inspection, a hole was found on the load plate cover.This defect affects the water tight seal of the device.Review of the archive data found two ua error messages that occurred on (b)(6) 2017.However, the reporter is unable to provide either the ua error message or date when the event occurred.Functional testing could not be performed.The platform displayed a ua 16 (timeout during take-up) error message upon powering on the device.The ua 16 is unrelated to the primary complaint, since the platform (at the time of the event) was able to provide the patient 3 compressions.Further evaluation of the device found that the drive train motor was defective.Device history record (dhr) 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).Case#2 ccr 30740 mfr 3010617000-2017-00263.Case#3 ccr 30741 mfr 3010617000-2017-00277.Case#4 ccr 30742 mfr 3010617000-2017-00254.

Event Description

On an unknown date at 01:05, a (b)(6) female patient (weighing (b)(6)) went into cardiac arrest while hospitalized in the cardiac medical department.The event was witnessed by the attending rn.The cpr team was requested to the patient's room and manual cpr began upon the teams' arrival.At 01:07, the autopulse platform (sn: (b)(4)) was placed.The platform provided 3 compressions before an unknown user advisory (ua) message was displayed.The platform then stopped compressions.Manual cpr was restarted and continued for an unspecified amount of time.The patient survived the cardiac arrest and was discharged on an unspecified date.According to the reporter, the health care team believes the cause for the ua is related to patient's scleroderma.The patient's skin was noted to be extremely taut.According to the reporter, the platform may not have been able to sense patient's circumference.The cause of cardiac arrest is unknown.No further information was provided.There is no known patient consequence reported.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#1 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 provided 3 compression before it stopped and an unknown user advisory (ua) message was displayed.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 alleged stoppage of the autopulse.In final conclusion, the autopulse performed as intended and improper use of the autopulse may have contributed to sudden stoppage.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 march 9, 2017, therefore a review of the autopulse's archive was performed from january 12, 2017 to march 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).The autopulse stoppage was potentially due to the stiffness of the patient, i.E., scleroderma.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: 6464693
• MDR Text Key: 72338018
• Report Number: 3010617000-2017-00260
• 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
• 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: 03/09/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 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
• Patient Age: 38 YR
• Patient Weight: 85