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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

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

Event Date 04/08/2024

Event Type  malfunction  

Event Description

During shift check, the autopulse platform (b)(6) displayed the user advisory (ua) 45 (not at "home" position after power-on/restart) message, and the lifeband could not be retracted.The customer also noted that the drive shaft was stiff.There was no patient involvement.

Manufacturer Narrative

The customer's complaint that the autopulse platform (b)(6) displayed the user advisory (ua) 45 (not at "home" position after power-on/restart) message was confirmed during the functional testing and the archive data review.The root cause of the reported ua45 was the drive shaft not being at the "home position." the ua45 advisory message can be easily cleared by pulling up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.However, in this case, it was noticed that the encoder drive shaft was difficult to rotate and exhibited binding and resistance, confirming the customer's reported complaint of a stiff drive shaft.The likely root cause was due to normal wear and tear of the platform.This might have caused the user difficulty pulling up the lifeband completely before turning the device on.The autopulse platform was manufactured in 2018 and is six years old.Upon visual inspection, no physical damage was noted.The archive data indicated multiple ua45 advisory messages, confirming the reported complaint.The autopulse platform failed functional testing due to ua45 displayed upon power-up, confirming the reported complaint.The drive shaft and clutch plate were cleaned and deburred to address the stiff driveshaft, and the drive shaft was rotated to the home position to address the ua45 advisory message.Upon further testing, the autopulse platform failed brake gap inspection.The brake gap was wide and out of specification, which was unrelated to the reported complaint.The brake gap was adjusted within the specification to address the observed problem.A load cell characterization test confirmed that both cell modules function within the specification.Following service, 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 there was no previous history of complaints reported for the autopulse platform with sn (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: 19149489
• MDR Text Key: 341286181
• Report Number: 3010617000-2024-00362
• 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: Foreign,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

• 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: 04/08/2024
• 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: 02/21/2018
• 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