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	Insufficient Information (4580)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (b)(6) displayed fault code 08 (motor controller malfunction) was confirmed in the archive data but was not confirmed during functional testing.The returned autopulse platform functioned as intended, and the reported fault code 08 was not replicated.No physical damage was observed on the returned autopulse platform during visual inspection.The archive data review showed multiple fault codes 08 (motor controller fault detected) on the customer's reported event date, confirming the reported complaint.Fault code 08 was cleared and did not reproduce during functional testing at zoll.User advisory and fault code is normally a clearable error message, and it is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per zoll autopulse user advisory, fault, and alert id code reference: fault code 08 alerts the operator that the motor controller's built-in fault detection system signals a fault.This error occurs if the motor controller board or drive train motor is defective.This fault code may be cleared when the user presses restart/cycle power.The autopulse passed the preliminary functional test without any fault or error.Zoll is awaiting the customer's approval for repair.
Event or Problem Description
The customer reported that upon replacing the lifeband, the autopulse platform (b)(6) displayed fault code 08 (motor controller malfunction).Additionally, the customer requested zoll service to perform bio-cleaning of the platform.No further information was provided.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.

• 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19016517
• Report Number: 3010617000-2024-00283
• Device Sequence Number: 20828462
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2024

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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2011
• 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