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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform in complaint for investigation.A final report will be submitted when the product is returned, and investigation has been completed.The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr, adjunctive use only indication is prominently displayed on device labels and in the device manual.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions when effective manual cpr is not possible.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.The autopulse is intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the trained 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.

Event Description

The customer reported that during their last autopulse training session conducted together with a zoll representative, one of the lifeband locking tab slots on the autopulse platform (sn (b)(4)) seemed loose.A mannequin was used during the demonstration, and the customer was reassured that the platform was functional.Later, the customer used this autopulse platform to resuscitate a patient in cardiac arrest.The patient was unconscious with anesthesia, lying on a hospital cardiac catheter bed.The platform was placed onto the bed, and the patient was then placed on the platform.Once the back side of the platform came into contact with the bed, the lifeband belt guard, near the loose locking tab slot, popped open and released the lifeband from the platform channel.Manual cpr resumed while the customer replaced the lifeband to troubleshoot the problem, but the issue was not resolved.The customer noticed that the lifeband belt guard near the suspected locking tab slot was still very loose, causing the lifeband cover plate to easily detach from the platform channel, despite appearing to be seated properly on the back side of the platform.Since the patient's condition was critical, and treatment options for this patient were limited without the autopulse, the customer elected to continue using the autopulse platform for resuscitation.The customer held the lifeband cover plate in place by laying his entire arm underneath the platform while another team member held the lifeband belt guard on the opposite side.After removing his arm from underneath the platform, it worked effectively delivering compressions.Return of spontaneous circulation (rosc) to the patient was not achieved, and the patient was later pronounced dead.The customer stated that the patient outcome was unrelated to the autopulse system, but the reported issue caused delays in providing automated compressions to the patient.

Manufacturer Narrative

D9 (returned to manufacturer) was updated.H4 (device manufacture date) was updated.The customer's reported complaint of a "loose fit of the lifeband" was not confirmed during testing performed at zoll.The autopulse platform was returned to zoll with a lifeband installed and a second lifeband in original packaging.The lifeband used during the reported event had been discarded by the customer.Zoll service personnel performed a thorough visual and functional inspection of the returned autopulse platform and found no anomalies.The platform functioned appropriately and as intended.Zoll concluded that the root cause of the customer's reported complaint was most likely related to the type of mattress or bedding used during the reported incident together with the possibility that the user might have pushed or "dragged" the autopulse underneath the patient to position them for cpr.The pressure of the bedding against the lifeband belt guard could potentially have caused it to become loosened or detached.The autopulse user guide states that the patient should be sat upright at the waist and the autopulse should be positioned under the patient.During visual inspection of the autopulse, no physical damage was observed.Platform's lifeband channel (die-cast) was thoroughly inspected, and no dimensional or mechanical issues were found that could have caused or contributed to the reported complaint.A thorough review of the autopulse platform archive showed the following: on the reported event date, the customer inserted a fully charged autopulse li-ion battery into the platform with a capacity of 1440 mah.Approximately 7 hours later, likely during the resuscitation deployment, the platform performed a total of 442 compressions without interruptions.The platform was then powered off by the user for about 17 minutes.When the autopulse platform was powered back on again, it displayed user advisory (ua) 45 (not at "home" position after power-on/restart), unrelated to the reported complaint.This advisory will occur if the driveshaft is not at its "home" position when the autopulse is powered on.The user powered off and on the autopulse, but the ua45 advisory message persisted.The ua45 was cleared after the second powering off/on, and autopulse platform performed a total of 1125 compressions until it stopped compressions with a displayed warning 1 (low battery warning), followed by user advisory (ua) 17 (max motor on-time exceeded during active operation), unrelated to the reported complaint.User advisory 17 followed by a warning 1 indicates that the battery has a low capacity.The archive confirmed that the battery's capacity at this time had dropped to 663 mah.Therefore, the platform functioned as intended at that time.The user did not replace the battery but powered on the platform again.Subsequently, the autopulse platform performed another total of 221 compressions with no issues until the device was powered off by the user.The archive review did not contain any indications that the lifeband was loose or was not securely attached to the platform during this deployment.Autopulse user advisories are normally clearable error messages designed into the platform to alert the operator that autopulse has detected one of several conditions.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.Per the autopulse maintenance guide, warning 1 indicates that the battery needs to be charged because less than 5 minutes of battery voltage is left.The recommended action is to take for this type of user advisory is to replace the battery and press restart to clear the warning.Per the autopulse hangtag - advisory codes description and action, user advisory 17 is an indication that the lifeband is twisted, or the 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.The autopulse platform passed the initial functional test and a load cell characterization test without any fault or error.During further inspection, a known-good lifeband was installed on the autopulse platform, and they were subjected to run-in testing using a normal-sized manikin for 45 minutes in 30:2 mode followed by 40 minutes in continuous mode.They were then tested with the 95% large resuscitation test fixture (lrtf) for 40 minutes in 30:2 mode followed by 35 minutes in continuous mode.The autopulse platform passed these tests with no interruptions.The zoll service personnel then tested the platform with both of the customer's returned lifebands.Each lifeband was properly installed and secured in place on the platform.The autopulse platform was tested with each customer lifeband using a 95% large resuscitation test fixture (lrtf) for about 30 minutes in 30:2 mode and 30 minutes in continuous mode.A subsequent lifeband retention check which includes vigorous shaking did not dislodge the lifebands from the platform.Zoll service personnel additionally dragged the platform with lifebands along an exercise/yoga mat, and the lifebands were not dislodged and remained securely attached to the platform.The customer's reported complaint of lifeband looseness could not be replicated.Following service including a brake gap inspection, the autopulse platform passed all testing criteria.Zoll has concluded that the root cause of the customer's reported complaint was most likely related to the type of mattress or bedding used during the reported incident together with the possibility that the user might have pushed or "dragged" the autopulse underneath the patient to position them for cpr.The pressure of the bedding against the lifeband belt guard could have caused it to become loosened or detached.The autopulse user guide states that the patient should be sat upright at the waist and the autopulse should be positioned under the patient.Zoll uk regional sales managers have been informed and will provide this information to the relevant autopulse team members.They will determine whether supplemental training needs to be provided to the customer.The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr, adjunctive use only indication is prominently displayed on device labels and in the device manual.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions when effective manual cpr is not possible.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.The autopulse is intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the trained 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.

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16456936
• MDR Text Key: 310412727
• Report Number: 3010617000-2023-00203
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2019
• 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