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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

During preventative maintenance (pm), the autopulse platform (sn (b)(6) failed functional testing with user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).A load cell characterization test was performed and revealed that load cell #2 was over-reporting, triggering the ua07 advisory message.The broken cover and load cell failure were likely attributed to mishandling such as a drop, or the age of the device.The autopulse platform was manufactured in september 2015 and is over 8 years old, well beyond its expected service life of 5 years.The malfunctioning load cell was replaced to remedy the ua07 advisory message.Upon visual inspection, the bottom enclosure was observed cracked with broken screw bosses, unrelated to the noted ua07 advisory message.The likely root cause of this physical damage is user mishandling, such as a drop.The bottom enclosure was replaced to address the problem.During further inspection, it was noted that the encoder driveshaft was stiff and did not rotate smoothly, unrelated to the noted ua07 advisory message.The root cause was due to the sticky driveshaft clutch area, likely related to the age of the device and non-usage of the platform for an extended period of time.Based on the archive data, the last time that the platform was powered on was in (b)(6) 2023.The impact of the sticky clutch was not severe enough to make the platform non-functional.The clutch plate was deburred to remedy the problem.Following service, a brake gap inspection was performed and verified the brake gap was within the specification.Another load cell characterization test was performed and confirmed that both cell modules were functioning within the specification.The autopulse platform was subjected to run-in test(s) using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without 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 (b)(6).

Event Description

During preventative maintenance (pm), the autopulse platform (sn (b)(6) failed functional testing with user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).No patient involvement.

• 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19149598
• MDR Text Key: 341127964
• Report Number: 3010617000-2024-00329
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

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: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2015
• 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