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

Model Number MODEL 100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

The device associated with this complaint has been received, however, the investigation is pending.A follow-up report will be filed when the investigation has been completed.A minor cut from the wire of the autopulse platform was causal related to the device and a procedure.It was not a serious adverse event.Death was not related to the minor cut from the wire of the autopulse platform.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.Out-of-hospital cardiac arrest (ohca) is one of the main causes of death in industrial nations.About 25% of patients survive this event and make it to the hospital, and even fewer patients survive after 24 hours (nichol, nejm, 2015).In the united states, survival to hospital discharge after non-traumatic emergency medical services-treated cardiac arrest with any first recorded rhythm was 10.6% for patients of any age.Of the bystander-witnessed out-of-hospital cardiac arrests in 2011, 31.4% of victims survived to hospital discharge (mozaffarian, circulation, 2016).Death is an expected outcome for ohca.In this case, death was not related to the minor cut from the wire of autopulse platform.

Event Description

A 63-year-old white male (350lbs and 6'2") patient who was in full cardiac arrest, sustained a minor cut from the frayed head restraint wire of the autopulse platform (sn (b)(6)), resulting in minor bleeding to the back of the head.The crew successfully controlled the bleeding by applying the towel.The autopulse platform performed compressions and functioned properly during the call, however, a return of spontaneous circulation (rosc) to the patient was not achieved, and the patient was pronounced dead.Per the customer, the patient's death was unrelated to the cut.

Manufacturer Narrative

The customer reported a complaint that one of the head restraint wires on the autopulse platform (sn (b)(6) ) observed frayed was confirmed during the visual inspection as both wire strands of the top cover were frayed.The damaged or cut head restraints do not render the autopulse platform non-functional.The head restraint wire could have been cut to free the patient from the platform, or the user could have been lifting the platform by holding the head restraints, likely due to user mishandling.The top cover was replaced to remedy the damage.Further visual inspection revealed, unrelated to the reported complaint, that the encoder drive shaft does not rotate smoothly and exhibits binding and resistance.The root cause was the sticky driveshaft clutch area, usually caused by sharp edges from all 12-hex edges of the armature plate or burrs on the clutch rotor's surface, likely attributed to normal wear and tear.The sticky clutch's impact was not severe enough to make the platform non-functional.The clutch plate was deburred to remedy the problem.The autopulse platform was manufactured in 2013 and is almost 11 years old, beyond its expected service life of 5 years.A review of the archive data showed a user advisory (ua) 02 (compression tracking error)error message occurred around the customer's reported event date, unrelated to the reported complaint.The user advisory was cleared by the customer and was not duplicated during the platform testing.User advisory is normally a clearable error message and is designed into the autopulse platform to alert the operator that autopulse has detected one of several conditions.Per the battery hangtag - advisory codes description and action, user advisory 02 is an indication that 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.The platform failed functional testing due to the (ua) 45 advisory message displayed upon powering up the platform, unrelated to the reported complaint.The driveshaft was rotated to the "home" position to remedy the error.However, the platform failed to achieve take-up and inability to perform compression, and displayed a fault code 29 (loss of brake connectivity), unrelated to the reported complaint.Investigation revealed a failed pdb.The pdb was replaced to remedy the fault.Following service, the brake gap inspection was performed and verified the brake gap was within the specification.A load cell characterization test was performed and confirmed that both cell modules function within the specification.The autopulse platform passed the run-in and final tests without fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for the autopulse platform with serial number (b)(6).

Event Description

A 63-year-old white male (350lbs and 6'2") patient with a history of diabetes who was in full cardiac arrest sustained a minor cut from the frayed head restraint wire of the autopulse platform (sn (b)(6) ), resulting in minor bleeding to the back of the head.The crew successfully controlled the bleeding by applying the towel.The autopulse platform performed compressions and functioned properly during the call; however, a return of spontaneous circulation (rosc) to the patient was not achieved, and the patient was pronounced dead.Earlier in the day, the patient's family contacted emergency services to report that the patient had flu-like symptoms and was hard to wake up.The patient expressed his exhaustion, saying his relatives would transport him to the emergency room.Per the customer, the patient's death was unrelated to the cut.The cause of death is unknown.

• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 18975665
• MDR Text Key: 338553326
• Report Number: 3010617000-2024-00237
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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 Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2013
• 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 Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 350 KG