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	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn 21573) displayed fault code 27 (encoder fault (> 3000 rpm)) and user advisory "(ua)34" (encoder failure) error messages was confirmed during functional testing and archive data review.The root cause of the noted faults was the defective encoder gearbox, likely due to the aging of the device.The autopulse platform was manufactured in january 2008 and is over 14 years old, well beyond its expected service life of 5 years.Upon visual inspection, unrelated to the reported complaint, the load plate cover defected with the hole that affects the watertight seal.The observed physical damage appeared to be the characteristics of user mishandling.The load plate cover needs to be replaced to address the observed issue.Archive data review showed occurrence of multiple fault code 27 and ua34 errors around and on the reported event date, thus confirming the reported complaint.The autopulse platform failed preliminary functional testing due to the fault code 27 and ua34 error messages, thus confirming the reported complaint.The root cause of fault code 27 and ua34 error was due to a defective encoder gearbox.To remedy this error, the encoder gearbox need to be replaced.Further functional testing, the load cell characterization test failed.The root cause of the noted failure was due to defective load cells, unrelated to the reported complaint.To remedy the observed issue, the load cells need to be replaced.Waiting on customer's approval for service 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)(4).
Event or Problem Description
During patient use, the autopulse platform (sn (b)(4) displayed fault code 27 (encoder fault (> 3000 rpm)) and user advisory "(ua)34" (encoder failure) error messages.No consequences or impact to the patient.

• 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: 15372241
• Report Number: 3010617000-2022-01510
• Device Sequence Number: 11194469
• Product Code: DRM
• UDI-Device Identifier: 00849111000079
• UDI-Public: 00849111000079
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2022

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: 8700-0700-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2008
• 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