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 04/22/2020

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 05/12/2020 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

During patient use, the autopulse platform (sn: (b)(4)) displayed fault code 16 (timeout moving to take-up position) error message.The user switched to manual cpr.No further information was provided by the customer.Patient's status information was requested, but the customer did not provide a response; therefore, patient's status is unknown.

Manufacturer Narrative

During service, the autopulse platform stopped compressions multiple times due to user advisory (ua) 02 (compression tracking error) error message, unrelated to the reported complaint.The root cause was due to defective load cell modules and the defective drivetrain, likely attributed to normal wear and tear.The defective drive drivetrain and both defective load cell modules were replaced to remedy the fault.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.

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn: (b)(6)) displayed fault code 16 (timeout moving to take-up position) error message" was confirmed based on the archive data review and during functional testing.The root cause for the reported complaint was due to the corrosion on the brake housing area of the drivetrain motor, likely due to humidity.A review of the autopulse platform archive revealed that frequent daily checks were performed by the customer, but the storage condition of the platform is not known.This type of corrosive damage is indicative of either usage of the autopulse platform and/or indicative of storing the device in a location with high ambient humidity.The autopulse platform is a reusable device and was manufactured in september 2008, and it is almost 12 years old, well beyond its expected service life of 5 years.During visual inspection, multiple cracks were observed at the top cover and multiple cracks were found 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 and/or due to mishandling.The archive data was reviewed and revealed multiple fault code 16 (timeout moving to take-up position) error messages to have occurred around the customer's reported event date; thus, confirming the reported complaint.The autopulse platform failed initial functional testing due to fault code 16 error message displayed during take-up; thus, confirming the reported complaint.The investigation findings revealed the autopulse platform did not achieve the target depth for take-up within the specified time.It was noted that the drivetrain 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 drivetrain motor to activate the brake.The brake gap inspection was performed and verified that the brake gap was within the specification.Upon further functional testing, the platform stopped after performing a few compressions due to fault code 27 (encoder fault), unrelated to the reported complaint.The autopulse platform stopped compressions because the encoder indicated that the drive shaft 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 the defective integrated encoder gearbox, likely attributed to normal wear and tear.The defective integrated encoder gearbox will be replaced to remedy the issue.Awaiting customer's approval for repair.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)(6).

• 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: 10054705
• MDR Text Key: 191860690
• Report Number: 3010617000-2020-00479
• 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,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• 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: 05/12/2020
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1