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

Model Number MODEL 100

Device Problem No Display/Image (1183)

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

Event Date 03/26/2024

Event Type  malfunction  

Event Description

The customer reported that the lcd screen of the autopulse platform (b)(6) was blank during a shift check.Per customer, the leds near the lcd screen were green as expected, but the display didn`t show any parameters.The customer troubleshot the issue by changing batteries, but the problem persisted.No patient involvement.

Manufacturer Narrative

The reported complaint that the lcd screen of the autopulse platform (b)(6) was blank was not confirmed during the visual-functional inspection.No problem was found, and the autopulse platform functioned as intended.Visual inspection showed a vertical crack going through one of the screw fittings of the front enclosure, unrelated to the reported complaint.The observed physical damage could be attributed to wear and tear or user mishandling, such as a drop.The autopulse platform was manufactured in (b)(6) 2013 and is over 11 years old, well beyond its expected service life of 5 years.The front enclosure was replaced to address this issue.Reviewing the autopulse platform's archive data didn't show any significant discrepancies or error messages.The autopulse platform passed initial functional testing without any fault or error.The autopulse platform was tested with multiple known-good test batteries, and the platform's on/off power button was pressed about 10 times.Each time, the autopulse platform powered on with no issues, the lcd screen was clear and the parameters on the screen were clear and readable.The lcd screen connector and all the wiring cables were checked, and no issue was found.Subsequently, the autopulse was subjected to a run-in test using instrumented manikin and large resuscitation test fixture (lrtf) for approximately 15 minutes each, and the platform passed the tests without any issues.Zoll is awaiting the customer's approval for repair.

• 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19140793
• MDR Text Key: 340806810
• Report Number: 3010617000-2024-00324
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• 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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2013
• 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