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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (serial #(b)(4) displayed fault code 16 (timeout moving to take-up position) error message was confirmed during the initial functional testing and archive data review.The probable root cause for the reported complaint was corrosion on the brake housing area of the drivetrain motor.Per archive, the customer did not perform frequent daily checks.This type of corrosive damage is indicative of infrequent daily checks, as a result of user mishandling.No physical damage was observed on the autopulse platform during visual inspection.During archive data review, multiple fault code 16 were recorded, 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.To remedy this issue, the brake assembly was cleaned using ipa (isopropyl alcohol).The brake gap inspection was performed and verified the brake gap was within the specification.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 return autopulse platform passed all functional testing.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint for autopulse with serial number (b)(4).
Event or Problem Description
Customer reported that the autopulse platform (serial #(b)(4) displayed fault code 16 (timeout moving to take-up position) error message.No further information was provided.Patient use information was requested but no additional information was provided, therefore patient use is unknown.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 10525657
• Report Number: 3010617000-2020-00866
• Device Sequence Number: 3203954
• Product Code: DRM
• UDI-Device Identifier: 00849111001151
• UDI-Public: 00849111001151
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1