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

Model Number MODEL 100

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the display of the autopulse platform (sn)(b)(6) is shorting and cutting out was not confirmed during review of the archive data or functional testing.The autopulse platform powers on and passed functional testing without any fault or error, performing as intended.During visual inspection, cracks were observed in the top cover and front and bottom enclosure, and the udi label was damaged.The observed physical damages were unrelated to the reported complaint and appeared to be the characteristics of user mishandling.The top cover, front and bottom enclosures, and udi label were replaced to address the damages.Also unrelated to the reported complaint, a sticky clutch was found.The impact of a sticky clutch was not severe enough to make the platform non-functional.The cause for the sticky clutch could be due to normal wear and tear.The autopulse platform was manufactured in 2018 and is 6 years old, past its expected serviceable life of 5 years.The clutch plate was deburred to address the observed problem.Upon review of the archive data , multiple user advisory (ua) 12 (lifeband not present) error messages were observed, unrelated to the reported complaint.The autopulse platform passed the initial functional testing without fault or error.The customer reported complaint was not reproduced.The (ua) 12 observed in the archive was also not reproduced.The reset switch was within specification.The (ua) 12 was most likely due to no clip or lifeband being present at the time of power up.User advisory is a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the battery hangtag - advisory codes description and action, user advisory 12 is an indication that the autopulse has detected that the lifeband is not properly installed.The recommended actions to take for this type of user advisory are: ensure that the band clip (underneath the device) is properly seated in the drive shaft can freely rotate after insertion.Following service, the autopulse platform passed run-in test without any fault or error.The autopulse platform passed the final testing without any fault or error.

Event Description

The customer reported the display of the autopulse platform (sn)(b)(6) is shorting and cutting out.No visible damage was noted.No additional information is available.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: 18661023
• MDR Text Key: 334785246
• Report Number: 3010617000-2024-00105
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2018
• 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