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

Model Number MODEL 100

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

The customer complaint of the autopulse platform sn (b)(6) was that it made a clicking noise, showed a red alert caution light, and displayed no message on the lcd, which was confirmed during the functional testing.The root cause of the reported complaint was a failed processor board, which was likely attributed to failed component(s).Upon visual inspection, unrelated to the reported complaint, a small crack across the screw well area of the front enclosure handle was noted.The likely cause of the observed physical damage was user mishandling, such as a drop.The front enclosure needs to be replaced to address the observed physical damage.Unable to perform the initial functional test due to the device not fully booting up, and the archive could not be recovered, confirming the reported complaint.The processor pca assembly needs to be replaced to address the reported complaint.Zoll is awaiting customer approval for service 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 sn (b)(6).

Event Description

The customer reported that upon powering up the autopulse platform sn (b)(6).The device made a clicking noise, showed a red alert caution light, and displayed no message on the lcd.The customer tried to resolve the observed problem by adjusting the lifeband, replacing the li-ion battery, and checking the vents per the manual, but the issue persisted.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
• 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: 18588320
• MDR Text Key: 333852278
• Report Number: 3010617000-2024-00077
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2024

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: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2021
• 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