MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  malfunction  

Event Description

The customer reported that the autopulse platform (sn (b)(6)) displayed "system error, out of service, revert to manual cpr".The customer also reported the autopulse platform consistently makes a clicking sound upon powering up.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.

Manufacturer Narrative

Zoll has not received the autopulse platform in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.

Event Description

During shift check, the autopulse platform (sn (b)(6)) displayed "system error, out of service, revert to manual cpr".The customer also reported the autopulse platform consistently makes a clicking sound upon powering up.No patient involvement.

Manufacturer Narrative

D9 (returned to manufacturer) was updated.H4 (device manufacture date) was updated.The reported complaint of the autopulse platform (sn (b)(6) displaying "system error, out of service, revert to manual cpr" and continuously making a clicking sound upon powering up was confirmed during functional testing.An archive review could not be performed because the data could not be downloaded.Therefore, the specific type of system error could not be identified.The system error's root cause was the malfunctioning processor board due to failed component(s).Visual inspection of the returned autopulse platform showed no physical damage.Archive data review could not be performed because the data could not be downloaded, most likely due to the processor board failure.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message while continuously making a clicking sound upon power up, confirming the customer's reported complaint.The malfunctioning processor pca assembly was replaced with a known-good service part to remedy the system error.Subsequently, the autopulse platform was tested with the large resuscitation test fixture (lrtf) for 6 minutes, and the platform passed the test without any fault or error.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with serial number (b)(6).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: 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: 18853044
• MDR Text Key: 337073608
• Report Number: 3010617000-2024-00197
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1