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 02/26/2024

Event Type  malfunction  

Event Description

During preventative maintenance on (b)(6) 2024, the display of the autopulse platform sn (b)(6) was readable but showed lines through the display.No patient involvement.

Manufacturer Narrative

During preventative maintenance on (b)(6) 2024, the display of the autopulse platform sn (b)(6) was readable but showed lines through the display.The root cause was due to a failure of the lc display, likely attributed to the age of the device.The platform was manufactured in 2013 and is over 11 years old, past the service life of 5 years.During visual inspection, the front and bottom enclosures and top cover were observed to be cracked/damaged.The observed physical damages appeared to be the characteristic of user mishandling.The front and bottom enclosure and top cover were replaced to address the damage.The lc display was readable but showed lines.The display was replaced to remedy the issue.The archive data showed user advisory (ua) 41 (patient surface temperature sensor malfunction) error message, unrelated to the lcd issue.The autopulse platform passed initial functional testing without any faults or errors.The platform passed the load cell characterization test without issue.The (ua) 41 seen in the archive could not be reproduced during functional testing.Nevertheless, the temperature sensor was replaced as a preventive precautionary measure, as there may have had some intermittent technical problems that could not be directly identified during the functional testing.Following service, 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.Historical complaints were reviewed for service information related to the reported issue 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: 18938062
• MDR Text Key: 338081018
• Report Number: 3010617000-2024-00232
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/19/2024

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: Other
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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