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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/23/2022

Event Type  Injury  

Event Description

The autopulse platform (sn (b)(4)) was used to resuscitate a patient in cardiac arrest.The patient was approximately 220 lbs.And had a shunt in her arm.The medical history of the patient suggested kidney problems requiring dialysis or the presence of an arteriovenous (av) fistula.The crew clamped the shunt on the scene and performed manual cpr for about 5 minutes before using the autopulse.The autopulse platform was placed on the stretcher's mattress pad, and then, the patient was placed on the platform.After compressions for about 90 seconds, the autopulse platform stopped and displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).The crew re-adjusted the lifeband and re-positioned the patient multiple times with no success.Therefore, the crew switched to manual cpr.The customer stated that the crew had left the platform under the patient for the entirety of the call, despite not being able to reset the platform.Upon arrival at the emergency department, the crew noticed that the shunt had dislodged.The customer stated that after 90 seconds of autopulse compressions, nothing was noted from the shunt.According to the customer, manual compressions and patient movement to the emergency department bed may have dislodged it.Dislodgment of the shunt resulted in a large amount of blood getting on the platform, having blood entering inside of the platform.Therefore, the customer requested the platform to be bio-cleaned during evaluation and service at zoll.The customer is unaware of the approximate weight and size of the manual cpr provider(s).As reported, there was no adverse effect or delay to patient care.

Manufacturer Narrative

The reported complaint that "the autopulse platform (sn (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large)" was not confirmed during archive data review or functional testing.During the investigation, a load cell characterization test was performed and confirmed both load cell modules were functioning within the specification.The autopulse platform functioned as intended, and no device malfunction was found.The reported event that "dislodgment of the shunt from the patient's arm resulted in a large amount of blood entering the platform" was not confirmed during the platform's open-case inspection.The zoll service specialist removed both the front and bottom enclosures and observed no trace of blood or fluid ingress.The interior of the autopulse platform did not require bio-cleaning.During visual inspection, the top cover as well as the front and bottom enclosures were observed damaged, unrelated to the reported complaint.The photos provided by the zoll service team revealed multiple large cracks, scratches, and breakages at the front-end area of the front enclosure.A large crack was on the top cover, close to the lower left-hand corner.In addition, there were multiple cracks in the screw well area of the bottom enclosure.The observed physical damages appeared as harsh impacts due to user mishandling.The damaged covers and associated parts will be replaced to address the issues.The platform was further examined and unrelated to the reported complaint, it was noted that the power distribution board (pdb) revision level was below 6 and needed to be updated, attributed to the age of the platform.The autopulse platform was manufactured in june 2007 and is over 15 years old, well beyond the expected service life of 5 years.A review of the archive data revealed that the recorded date and time in the archive were corrupted, showing that the last time the autopulse platform was powered on was (b)(6) 2020.Therefore, the date of the customer's reported event was not captured in the archive.The root cause of the corrupted archive may have been due to repeated power cycling of the device or due to an unexpected shutdown of the device.The apvision3 software was used to clear and reinitialize the system software, including the archive data, and the latest firmware was re-installed on the autopulse platform to remedy the fault.The autopulse platform passed initial functional testing without any fault or error.The reported ua07 advisory message was not duplicated, and the load cell characterization test confirmed both cell modules were functioning within the specification.The likely root cause for the reported ua07, which was not captured in the corrupted archive data, was either due to the patient or the platform being out of position, placed on an uneven surface, or the patient not properly centered/aligned on the platform.Zoll is awaiting the customer's approval for repair.The event of "shunt was dislodged from patient's arm" was not serious since the event didn't meet any criteria of seriousness per regulations.According to currently available information, the event of "shunt was dislodged from patient's arm" can be caused by manual cpr performance, moving the patient during the call, and autopulse compressions with adjusted patient's position.The event was possibly related to the autopulse device since the connection of the reported event using autopulse cannot be ruled out.

• 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: 15655808
• MDR Text Key: 302247550
• Report Number: 3010617000-2022-01860
• 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 Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Date Returned to Manufacturer: 10/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2007
• 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