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 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(4) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message was confirmed during archive review but not during the functional testing.The user was able to clear the (ua) 45 error before the platform was returned to zoll for evaluation.The root cause for the (ua) 45 error was due to the driveshaft not being at the "home position".The (ua) 45 error 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, during further testing, it was noticed that the encoder driveshaft could not rotate smoothly and exhibited binding and resistance.This might have caused difficulty for the user to clear the (ua) 45 error message.Upon visual inspection, unrelated to the reported complaint, noticed the cracked front and bottom enclosures.The probable root cause for the observed physical damage could be due to user mishandling such as a drop.The front and bottom enclosures were replaced to address the observed physical damages.As part of routine service during testing, the platform was examined, and unrelated to the reported complaint, the encoder drive shaft does not rotate smoothly and exhibits binding and resistance due to a sticky clutch plate.The sticky clutch plate needs to be deburred to address the issue.The cause for the sticky clutch could be due to the normal use of the device.The archive data review showed (ua) 45 error messages around the reported event date.Thus, confirming the reported complaint.In addition, unrelated to the complaint, the archive showed the presence of multiple (ua) 17 (motor on for too long during active operation) errors.The autopulse platform passed the initial functional testing without any fault or error.In addition, unrelated to the reported complaint, during further testing of the drivetrain motor, the investigation revealed that the drivetrain motor brake assembly air gap was too wide, and out of specification, possibly causing the intermittent occurrences of the (ua) 17 which were observed in the archive data.The brake gap was adjusted and cleaned to remedy the fault.Following service, the autopulse platform was subjected to the run-in test using the instrumented manikin followed by 95% patient large resuscitation test fixture (lrtf) with good known test batteries for 15 minutes each 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 complaint and there was no similar complaint reported for autopulse with a serial number (b)(4).

Event Description

During the shift check, the loaner autopulse platform (sn (b)(4) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message, and the driveshaft does not spin freely.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: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131
• MDR Report Key: 16066380
• MDR Text Key: 306326800
• Report Number: 3010617000-2022-02117
• Device Sequence Number: 1
• Product Code: DRM
• 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: 12/29/2022

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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2020
• 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