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 03/23/2024

Event Type  malfunction  

Event Description

During shift check, the customer noticed pixelated characters on the lcd of the autopulse platform (sn (b)(6)).No patient involvement.

Manufacturer Narrative

The customer's complaint that the lcd of the autopulse platform (b)(6) displays pixelated characters was not confirmed during the functional testing.The reported complaint was not reproduced during the functional testing.Nevertheless, the lcd screen was replaced as a preventive precautionary measure, as the lcd may have had some intermittent technical problems that could not be directly identified during the functional testing.The autopulse platform was manufactured in 2008 and is over 16 years old.Upon visual inspection, unrelated to the reported complaint, cut head restraints, chipped and cracked front enclosure handle around the screw well area, a missing screw from the channel drive train assembly, and multiple cracks on the bottom enclosure were noted.The cut head restraints do not render the autopulse platform non-functional.The patient's head restraint wire could have been cut to free the patient from the platform, or the user could have lifted the platform by holding the head restraints.The observed physical damages appear to be the characteristics of the harsh impact caused by user mishandling, such as a drop.The damaged parts were replaced to address the physical damages.Upon further inspection, unrelated to the reported complaint, it was noted that the encoder drive shaft does not rotate smoothly and exhibits binding and resistance.The root cause was the sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the clutch rotor's surface, likely attributed to normal wear and tear.The sticky clutch's impact was not severe enough to make the platform non-functional.The clutch plate was deburred to remedy the problem.The archive data review indicated corrupted dates and an inability to perform software updates.The observed archive issue is unrelated to the reported complaint, and the processor board was replaced to address the observed problem.The autopulse platform passes the functional testing without error or fault.The autopulse platform was subjected to a 5-minute run-in test using a large resuscitation test fixture (lrtf), and the platform functioned as intended.Although the reported lcd problem was not reproduced during the testing at zoll, an intermittent issue could not be ruled out.Therefore, the lcd screen was replaced as a preventive precautionary measure to address the reported complaint.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries for 15 minutes without fault or error.The autopulse platform passed the run-in and final tests without fault or error.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for the autopulse platform with (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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19149492
• MDR Text Key: 341434039
• Report Number: 3010617000-2024-00321
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• 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