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

Model Number MODEL 100

Device Problems Failure to Power Up (1476); Power Problem (3010)

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

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the autopulse platform however, the investigation is still in progress.A follow-up report will be submitted when the investigation has been completed.

Event Description

During shift check, the power button on the autopulse platform (sn (b)(4) does not power on when the power button was pressed, and it is pushed into the platform.No patient involvement.

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(6) ) does not power on when the power button was pressed, and button is pushed inside the platform" was confirmed during functional testing and during visual inspection.The root cause of the reported power issue was the damaged on/off power button switch, likely attributed to user mishandling.During visual inspection, the power button switch was damaged and being pushed inside the autopulse platform, thus confirming the reported complaint.The root cause of the damaged button was the broken bracket, likely attributed to mishandling such as a drop.Also, unrelated to the reported complaint, a lot of fluid ingresses corroded/damaged blue case (top cover) metalized coating and the channel die-cast was heavily contaminated, likely due to liquid entered the device.The top cover and channel die-cast needs to be replaced and the autopulse platform is also required to have bio-cleaning.The archive data review showed no significant discrepancies.The autopulse platform was unable to power on due to the power button switch was pushed inside the autopulse platform.The power button switch and bracket need to be replaced to address the reported power issue.Zoll awaiting 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 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: 16470977
• MDR Text Key: 310548926
• Report Number: 3010617000-2023-00192
• 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,Followup
• Report Date: 03/31/2023

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: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2017
• 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