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 01/11/2024

Event Type  malfunction  

Event Description

The customer reported that during shift check, the autopulse platform sn (b)(6)displayed a "system error, out of service, revert to manual cpr" message upon powering up.No patient involvement.

Manufacturer Narrative

The customer reported a complaint that the autopulse platform sn (b)(6) displayed a "system error, out of service, revert to manual cpr" message upon powering up was confirmed during the functional testing and review of the archive data.The root cause for the reported complaint was that the drive train motor brake assembly air gap was out of specification and was not adjustable, due to a defective drive train motor, likely attributed to a defective component.Upon visual inspection, unrelated to the reported complaint, damage was observed on the front enclosure.The observed physical damage appeared to be characteristic of user mishandling.The front enclosure will be replaced to address the observed physical damage.The archive data review indicated system error user advisory (ua) 139 (unable to hold compression position), thus confirming the reported complaint.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering on, thus confirming the reported complaint.The drive train motor was replaced to address the system error and for testing.Subsequently, the device was tested with an instrumented manikin and lrtf (large resuscitation test fixture) for approximately 15 minutes each with no issue.Upon service completion, the platform will be subjected to final functional testing to ensure that the device passes all testing criteria.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for autopulse platform with sn (b)(6).

• 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: 18642940
• MDR Text Key: 334746392
• Report Number: 3010617000-2024-00098
• 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: 02/05/2024

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: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2020
• 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