MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 04/30/2020 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

The autopulse platform (sn: (b)(4)) displayed user advisory (ua)41 (patient temperature sensor failure) error message upon powering up.As reported by the customer, the platform was stored in their ambulance and was not used for a while.Patient use information was requested, but no additional information was provided; therefore, patient use is unknown.

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn: (b)(4) displayed user advisory (ua)41 (patient temperature sensor failure) error message upon powering up" was confirmed based on the archive data review but not confirmed during the functional testing.No device malfunction was observed that could have caused or contributed to the reported ua41 error message.However, improper storage condition of the autopulse system most likely contributed to the occurrence of the ua41.As per the customer, the autopulse platform was stored in their ambulance and was not used for a while.The ambient storage condition (e.G.A fire truck sitting in a hot and humid environment and/or being exposed to direct sunlight for long hours) as well as using the platform on a soft surface that may block air vents will increase the internal temperature of the autopulse platform and cause the occurrence of ua41 error message.During visual inspection, multiple cracks were observed at the screw well area of the front and bottom enclosures, unrelated to the reported complaint.The root cause for the observed physical damages could be due to normal wear and tear.The autopulse platform was manufactured in october 2013, and it is almost 7 years old, exceeded its expected service life of 5 years.Front and bottom enclosures were replaced to address the physical damages.The autopulse platform failed initial functional testing due to fault code 16 (timeout moving to take-up position) error message displayed during take-up, unrelated to the reported complaint.Investigation findings revealed that the drive train motor had corrosion at the brake housing area.The brake assembly was seized from corrosion which prevented the brake to open or close during activation.The corrosion at the brake assembly was removed using ipa (isopropyl alcohol).After removing the corrosion, the autopulse platform was connected to a power supply and applied 12v to the brake cable of the drive train motor to activate the brake.The brake gap inspection was performed and verified that the brake gap was within the specification.During further functional testing, front and bottom enclosures were removed, and massive body fluid ingresses was observed inside the autopulse platform.The contamination had formed corrosion on the top cover metalized coating layer, unrelated to the reported complaint.The top cover was replaced to address the damage.In addition, the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance, unrelated to the reported complaint.The root cause for this issue is most likely due to sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor, likely attributed to normal wear and tear.The sticky clutch plate was deburred to address the issue.A review of the autopulse platform archive was performed, and it showed multiple ua41 (patient temperature sensor failure) error messages; thus, confirming the reported complaint.Based on the archive data, patient temperature sensor failure occurred with the sensors reading 127 °c.Blowing hot and cool air directly to the location of the temperature sensor mounted was performed, and as a result, the sensor responded respectively to the temperature increase/decrease.However, the temperature sensor was replaced as a preventive precautionary measure, as the sensor may have had some intermittent technical problems that could not be directly identified during the functional testing.Following service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10054711
• MDR Text Key: 191457218
• Report Number: 3010617000-2020-00489
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 05/20/2020
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1