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

Model Number MODEL 100

Device Problem Failure to Power Up (1476)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

During the device check, the on/off power button of the autopulse platform (sn (b)(6)) was noted inoperable (broken inward), and the battery lock was broken.In addition, the device requires bio-cleaning.No patient involvement.

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(6)) on/off power button is inoperable (broken inward) was confirmed during functional testing and the visual inspection.The power button was observed loose, torn, and pushed inside the platform, which would cause it to be inoperable intermittently.The root cause of the reported issue was likely attributed to user mishandling.The customer's secondary complaint of the broken battery lock was confirmed during the visual inspection as the battery latch was noted missing, likely attributed to user mishandling.The missing battery latch was replaced to address the issue.During further visual inspection, unrelated to the reported complaint, it was noted that both of the head restraints were cut from the top cover of the autopulse platform, likely attributed to mishandling.The head restraint wires could have been cut to free the patient from the platform or the user could have been lifting the platform by holding the head restraints.The cut or damaged head restraint does not render the autopulse platform non-functional.The top cover was replaced to address the observed damage.In addition, during visual inspection, unrelated to the reported complaint, noted a damaged battery bay compartment, and multiple cracks on the bottom enclosure.The observed physical damages appear to be the characteristics of the harsh impact caused by user mishandling, such as a drop.The damaged parts were replaced to address the physical damage.Since there was no evidence of biohazard material infiltration, no bio-cleaning was necessary.The autopulse platform passed the preliminary functional test without any issues.However, the power button was noted loose, torn, and pushed inside the platform, which might lead to intermittent functionality, thus confirming the customer's complaint.The damaged power button was replaced to address the observed issue.Upon review of the archive data, no significant discrepancies were found.Following service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for the autopulse platform with a 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 sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18919231
• MDR Text Key: 337854681
• Report Number: 3010617000-2024-00213
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• 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