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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2024

Event Type  malfunction  

Event Description

The customer originally reported that during patient treatment on february 11, the autopulse platform (sn (b)(6)) displayed a "system error, out of service, revert to manual cpr" message.It was further reported the platform makes a ticking sound and intermittently displays a blank screen.However, when the menu button is pressed, the screen shows "system error".The customer attempted to resolve the issue by repositioning the autopulse lifeband to no avail.Upon follow up, the customer reported the platform performed as intended during use on the patient.The treatment wasn't affected.The issues were found when putting the platform back in service.No patient involvement.

Manufacturer Narrative

The customer reported complaint that the autopulse platform (sn (b)(6)) displayed a "system error, out of service, revert to manual cpr" message was confirmed during the functional testing.The customer reported complaint that the device was making a clicking sound and intermittently displays a blank screen was also confirmed during functional testing.The root cause for the reported complaints was due to a failed processor pca board.During visual inspection, no physical damage was observed on the platform.The archive data could not be downloaded.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering on, thus confirming the reported complaint.The reported problems of device making clicking sound and blank screen were observed.It was observed that the device was stuck in a boot up self-test and was unable to pass it due to the system error.The failed processor pca board will be replaced to address the complaints.Upon service completion, the platform will be subjected to final functional testing to ensure that the device passes all testing criteria.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse platform with sn (b)(6).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18851904
• MDR Text Key: 337074457
• Report Number: 3010617000-2024-00198
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2024

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
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• 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