MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; 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 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint that "the autopulse platform (sn (b)(6)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large)" was not confirmed during the archive data or functional testing.During the investigation, a load cell characterization test was performed and confirmed both load cell modules were functioning within the specification.The autopulse platform functioned as intended, and no device malfunction was found.During visual inspection, the top cover, and the front and bottom enclosures were observed to be cracked.The observed physical damage was unrelated to the reported complaint and appeared to be characteristic of user mishandling, such as a drop, as reported by the customer.The top cover and the front and bottom enclosures were replaced to address the issue.The archive data review showed no significant discrepancies.The autopulse platform passed the functional testing with no error or fault.The (ua) 07 error message was not reproduced.A load cell characterization test confirmed that both cell modules function within the specification.Following the service, the platform passed the load cell characterization check.The autopulse platform passed the run-in test without any fault or error.The autopulse platform passed the final testing without any fault or error.

Event Description

The customer reported that the autopulse platform (sn: (b)(6)) was accidentally dropped by the hospital staff when transferring the patient from the platform to the hospital bed.After the call, the platform was tested and displayed a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.No patient involvement.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18708301
• MDR Text Key: 335537437
• Report Number: 3010617000-2024-00124
• Device Sequence Number: 1
• Product Code: DRM
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2018
• 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