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); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported the autopulse platform (sn (b)(6) ) is faulty.The device has only been used in a training environment.When placed under load with a manikin in place, the display screen begins to flicker and flash.The controls for the screen cease to work.This problem is intermittent and is exacerbated with movement of the device.No patient involvement.

Manufacturer Narrative

Zoll has not received the autopulse platform in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The reported complaint of when placed under load with a manikin in place, the display screen of the autopulse platform ((b)(6)) begins to flicker and flash and the controls for the screen cease to work intermittently was not confirmed during archive data review or functional testing.No device malfunction was observed during the functional testing and the autopulse platform performed as intended.Upon visual inspection, unrelated to the reported complaint, the top cover was observed to be cracked at the lower corner on the patient's left-hand side.The observed physical damage appeared to be the characteristics of user mishandling, such as a drop.The top cover was replaced to address the damage.Based on the archive review, no significant discrepancies were found.The autopulse platform passed the initial functional test without any fault or error at zoll san jose.The platform was tested with the large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.Despite all the testing, the customer reported complaint could not be reproduced.During testing by zoll canada, unrelated to the complaint, the platform displayed user advisory (ua) 19 (max applied load exceeded) error message when tested with the lrtf and it was noticed the drive shaft getting stuck intermittently.However, during testing in san jose, the (ua) 19 and the symptoms of the drive shaft getting stuck were not observed.The autopulse platform functioned appropriately and performed as intended.The customer has received a replacement autopulse platform.Therefore, the autopulse platform ((b)(6)) will not be returned to the customer and will be stored for future refurbish sale order requests.

• 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): ZOLLCIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18013101
• MDR Text Key: 326631751
• Report Number: 3010617000-2023-00904
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2023
• 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