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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

Event Type  malfunction  

Event Description

During shift check, the customer reported that the autopulse platform (sn (b)(4)displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) that could not be cleared.No patient involvement.

Manufacturer Narrative

The reported complaint that "the autopulse platform (sn (b)(4) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message that could not be cleared" was confirmed during functional testing and review of the archive data.The root cause of the (ua) 07 advisory message was the failure of both single point load cells.The cracked front enclosure and load cells failure were likely attributed to mishandling, such as a drop.During visual inspection, unrelated to the reported complaint, the front enclosure was observed to be cracked.The observed physical damage was unrelated to the reported complaint and appeared to be the characteristics of user mishandling.The front enclosure was replaced to address the issue.A review of the archive data showed user advisory (ua) 07; thus, confirming the reported complaint.The platform failed initial functional testing due to the (ua) 07 advisory message displayed upon powering up the platform; thus, confirming the reported complaint.Both single point load cells were replaced to remedy the complaint.Following service, the autopulse platform passed the load cell characterization check without issue.The platform also passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) for 15 minutes 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 autopulse platform with serial number (b)(4).

• 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: 16078261
• MDR Text Key: 306521148
• Report Number: 3010617000-2022-02091
• 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: 12/30/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2020
• 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