MAUDE Adverse Event Report: ZOLL CIRCULATION INC 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 03/25/2024

Event Type  malfunction  

Event Description

The customer reported during shift check, the display screen of the autopulse platform (b)(6) is unreadable.The platform powers on, immediately displays a thin black line that goes away, and only the backlight stays on.The platform was tested with other good autopulse li-ion batteries with the same result.No patient involvement.

Manufacturer Narrative

The reported complaint that the display screen of the autopulse platform (b)(6) is unreadable was confirmed during functional testing.The customer complaint was observed, however during evaluation after the bottom enclosure was removed, the customer reported complaint was cleared and could not be reproduced.However, the lcd screen was replaced as a precaution to prevent future reoccurrence.During visual inspection, unrelated to the reported complaint, the front enclosure was cracked.The observed physical damage appeared to be the characteristic of user mishandling.The front enclosure was replaced to address the issue.No significant discrepancy was found in the archive review.The autopulse platform failed initial functional testing due to the screen being unreadable, thus confirming the reported complaint.However, during evaluation when the bottom enclosure was removed, the issue was cleared.The autopulse platform was powered on and off several times and tested using different autopulse li-ion batteries, but the reported complaint was not reproduced.An internal inspection was performed, including inspections of the lcd board, pca board, and cable connector connection.No faults were found.However, the lcd screen was replaced as a precaution to prevent future reoccurrence.Following service, the autopulse platform passed the 15-minute run-in test without any fault or error.The autopulse platform passed the final testing 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 autopulse platform with sn (b)(6).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19154319
• MDR Text Key: 341287098
• Report Number: 3010617000-2024-00318
• 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
• Report Date: 04/22/2024

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: 04/05/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2018
• 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