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 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform sn (b)(6) displayed fault code 16 (timeout moving to take-up position)" was confirmed based on the review of the archive data and during functional testing.The root cause of the reported complaints was the seized brake gap of the drive train.The storage condition of the platform is not known, but a review of the autopulse platform archive revealed that frequent daily checks had not been performed.Required daily device checks per the zoll user manual and storing the autopulse in a low-humidity location help prevent the brake from seizing.During visual inspection, a cracked front enclosure was observed on the autopulse platform.The observed physical damage was unrelated to the reported complaint and appeared to be characteristic of user mishandling.The front enclosure was replaced to address the issue.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 slightly sticky clutch plate.The sticky clutch plate was deburred to address the issue.The cause for the sticky clutch could be due to the normal use of the device.The sticky clutch's impact was not severe enough to make the platform non-functional.The archive data was reviewed and revealed multiple fault code 16 around the customer's reported event date, confirming the reported complaint.Unrelated to the reported complaint, user advisory (ua) 12 (lifeband not present) error message was also observed.The user advisory is normally a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse hangtag - advisory codes description and action, user advisory 12 indicates that autopulse has detected that the lifeband is not correctly installed.The recommended actions for this type of user advisory are: ensure that the band clip (underneath the device) is correctly seated in the drive shaft and can freely rotate after insertion.The autopulse platform failed initial functional testing due to fault code 16, thus confirming the reported complaint.The inspection found the brake gap to be seized, preventing the lifeband from being retracted, causing fault code 16.Ipa (isopropyl alcohol) was used to clean and un-seize the brake gap.After cleaning, the brake gap inspection was performed, and it was verified that the brake gap was within the specification.Following service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries 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 previous history of complaints reported for the autopulse platform with serial number (b)(6).

Event Description

During training by the customer, the autopulse platform sn (b)(6) displayed fault code 16 (timeout moving to take-up position).The customer tried to troubleshoot; however, the issue persisted.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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18726905
• MDR Text Key: 335943265
• Report Number: 3010617000-2024-00156
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• 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