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

Model Number MODEL 100

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

The customer reported that during a shift check, they noticed the lcd screen of the autopulse platform (sn (b)(6)) was malfunctioning.The customer sent a picture showing that the lcd was scrambled and unreadable with missing pixels.No patient involvement.

Manufacturer Narrative

The reported complaint that the lcd screen of the autopulse platform (sn (b)(6)) was malfunctioning was confirmed during the visual-functional inspection.The root cause of the reported complaint was the malfunctioning lcd screen, likely due to failed components or mishandling, such as a drop.Visual inspection of the returned autopulse platform revealed a cracked front enclosure, unrelated to the reported complaint.The observed physical damage could be attributed to user mishandling.The front enclosure was replaced to address the issue.The archive data review showed no significant discrepancies.The autopulse platform powered up, but further functional tests could not be performed as the lcd screen was unreadable.The malfunctioning lcd display assembly was replaced to remedy the problem.Subsequently, the autopulse platform was tested with the large resuscitation test fixture (lrtf) for 15 minutes, and the platform passed the test without any fault or error.Following service, the autopulse platform was subjected to a final run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for the autopulse platform with serial number sn (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: 18297751
• MDR Text Key: 330150815
• Report Number: 3010617000-2023-01041
• 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: 12/08/2023

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: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2019
• 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