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

Model Number MODEL 100

Device Problem Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn: (b)(4)) failed to power up" was confirmed during functional testing.The root cause of the reported failure was a defective power distribution board (pdb) that resulted from fluid ingress into the autopulse platform due to user mishandling.During testing, the front and bottom enclosures were removed, and a massive amount of fluid ingress was found inside the autopulse platform, consistent with the customer's reported issue of "the platform was contaminated with body fluid." during visual inspection of the returned autopulse platform, it was observed that the lcd display was missing pixels, and the metallic inner surface of the top cover had been corroded.Both issues were attributed to fluid found inside the autopulse platform.Both the lcd display and the top cover were replaced to address the issues.Archive data could not be downloaded and reviewed because the autopulse platform failed to power up.During functional testing, the autopulse platform failed to power up due to the defective power distribution board; thus, confirming the reported complaint.The power distribution board (pdb) was replaced to remedy the issue.After replacing the defective pdb, when the autopulse was powered on, the platform displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).During power-on-self-test, the load sensing system detected a weight or load imbalance between the two load cells.Load cell characterization results confirmed both load cell modules over reported/defected, and they were replaced to remedy the fault.The root cause of the issue was as a result of the fluid ingress into the platform.In addition, the channel die-cast also exhibited corrosion due to the fluid ingress, and therefore, it was replaced.Upon further functional testing, the platform stopped after performing a few compressions due to fault code 27 (encoder fault).The autopulse platform stopped compressions multiple times to the fault code 27 as the encoder indicated that the driveshaft was turning too fast at the speed higher than 3000 rpm during compression, and therefore, the fault code 27 was triggered.The root cause was due to a defective integrated encoder gearbox, caused by the fluid ingress.The defective integrated encoder gearbox was replaced to remedy the issue.In addition, it was noted that the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance, unrelated to the reported complaint.The root cause was due to the 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.The sticky clutch plate was deburred to address the issue.Following service, the autopulse 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.The brake gap inspection was performed and verified the brake gap was within the specification.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for autopulse with serial number (b)(4).

Event Description

After patient use, the customer reported that the autopulse platform (sn: (b)(4)) would not power up.The platform was tested with multiple fully charged autopulse li-ion batteries; however, the issue persisted.In addition, it was reported that the platform was contaminated with body fluid.No further information was provided by the customer.No patient involvement.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10341923
• MDR Text Key: 201001422
• Report Number: 3010617000-2020-00724
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• 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: 07/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2015
• 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