MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE RESUSCITATION MODEL 100; 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	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has received the platform however, the investigation is still in progress.A follow-up report will be submitted when the investigation has been completed.
Event or Problem Description
During the device check, the autopulse platform (serial #(b)(4) displayed "system error, out of service, revert to manual cpr " upon powering on.No patient involvement.
Additional Manufacturer Narrative
The reported complaint that "the autopulse platform (serial # (b)(6) displayed "system error, out of service, revert to manual cpr " upon powering on was confirmed during functional testing.The root cause of the reported complaint was the defective processor board (pca), likely attributed to the aging of the device.The autopulse platform was manufactured in february 2015 and is 7 years old, past its expected service life of 5 years.Upon visual inspection, unrelated to the reported complaint, the battery compartment was observed to be damaged with a bent battery latch and cut battery cable.The observed physical damages appeared to be characteristic of user mishandling and/or an aging device.All the damaged parts were replaced to address the issues.The platform's archive data could not be downloaded likely attributed to the defective processor board (pca).The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering up the device.Therefore, the reported complaint was confirmed.The defective processor board (pca) was replaced to remedy the "system error, out of service, revert to manual cpr " message.In addition, unrelated to the reported complaint, the autopulse platform also failed functional testing due to the "fault code 27 (encoder fault)" error message.It was determined that the probable root cause of fault code 27 error was due to the drive train motor brake gap out-of-specification, likely attributed to wear and tear.The brake gap could not be adjusted to the manufacturing specifications and therefore, the drive train motor was replaced to remedy the observed issue.Following service, the autopulse platform passed 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.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse with serial number (b)(6).

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Common Device Name: 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: 13982756
• Report Number: 3010617000-2022-00303
• Device Sequence Number: 5554677
• Product Code: DRM
• UDI-Device Identifier: 00849111000031
• UDI-Public: 00849111000031
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022

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: 8700-0700-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown