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 09/07/2023

Event Type  malfunction  

Manufacturer Narrative

During the preventative maintenance (pm) on (b)(6), 2023, the backlight of the autopulse platform's (sn (b)(6)), lcd flickers briefly when switched on and the display has missing pixels.The root cause of the reported complaint was an lc display failure, likely attributed to the age of the device.The autopulse platform was manufactured in 2012 and is 11 years old, past the expected serviceable life of five years.Upon visual inspection, the backlight of the display flickers briefly when switched on and has missing pixels.The lc display was replaced to address the observed issue.Also, damage was observed on the front enclosure of the platform (the screw holder was broken on the inside).The observed physical damage appeared to be characteristic of user mishandling.The front enclosure was replaced.In addition, one of the head restraint wires on the top cover was cut/damaged.The damaged head restraint does not render the autopulse platform non-functional.The observed physical damage appeared to be characteristic of user mishandling, but contribution from wear and tear cannot be ruled out due to the age of the device.The top cover was replaced to remedy the issue.The autopulse platform passed the initial functional testing without any fault or error.After service, the autopulse platform was subjected to a run-in test.The platform passed without any fault or error.The autopulse platform passed the final testing without issues.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints for autopulse platform with sn (b)(6).

Event Description

During the preventative maintenance (pm) on (b)(6) 2023, the backlight of the autopulse platform's (sn (b)(6)), lcd flickers briefly when switched on and the display has missing pixels.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17818912
• MDR Text Key: 324280659
• Report Number: 3010617000-2023-00835
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• 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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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