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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform sn (b)(6) displayed user advisory (ua) 20 (position out of range) was confirmed during the archive review.The (ua) 20 was also confirmed during functional testing by the zoll chelmsford service team.The root cause of the (ua) 20 advisory message was that the drive shaft was not at "home" position, likely attributed to unintended user error.The zoll chelmsford service team cleared the error by accessing the admin mode to manually rotate the drive shaft to the home position to remedy the complaint.User advisories are normally clearable error messages and are designed into the platform to alert the operator that autopulse has detected one of several conditions.Per autopulse user advisory list guide, user advisory (ua) 20 occurs due to the encoder driveshaft not being within the normally acceptable range of positions.Typically, if the user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) is not resolved properly, it leads to ua20 because the driveshaft is not restored at its "home" position.To clear a ua20, return the driveshaft to its "home" position using the platform's administrative menu.During visual inspection, multiple cracks were observed in the screw well area of the front and bottom covers and multiple of the top cover's screw bosses were cracked, unrelated to the reported complaint.The observed physical damages appeared to be characteristic of user mishandling.The front, bottom, and top covers were replaced to address the observed physical damages.When both front and bottom covers were removed, fluid ingress was observed, unrelated to the reported complaint.The interior of the autopulse was bio-cleaned to remedy the issue.A review of the archive file showed upon powering on, the autopulse platform displayed multiple (ua) 20 error messages around the reported event date, thus, confirming the reported complaint.The drive shaft was not within the normal acceptable range of positions when the platform was powered on.The autopulse platform passed the initial functional testing without any fault or error at zoll san jose.The (ua) 20 was not reproduced.Unrelated to the reported complaint, the platform stopped compressions multiple times during the run_in test due to fault 27 (encoder fault).The fault was related to a failure of the power distribution board (pdb).The pdb was replaced to remedy the issue.Following service, the autopulse platform passed the run-in test 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 for autopulse platform with sn (b)(6).

Event Description

The customer reported the auto pulse platform sn b)(6) displayed user advisory (ua) 20 (position out of range).No additional information was provided.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18744531
• MDR Text Key: 335941849
• Report Number: 3010617000-2024-00161
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• 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: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2021
• 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