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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During patient use, customer reported that the autopulse platform (serial # (b)(4) stopped compression.The lifeband is in good position when used.Patient's status information was requested but the customer did not provide a response.
Additional Manufacturer Narrative
Zoll has received the platform however, the investigation is still in progress.A follow-up report will be submitted when the investigation has been completed.
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (serial # (b)(6)) stopped compression was not confirmed based on the review of the archive data and during functional testing.The autopulse platform was tested extensively but not fault or error.During visual inspection, no physical damage was observed on the autopulse platform.The archive data review indicated multiple ua45 error messages around the customer's reported event date, unrelated to the reported complaint.Also in the archive, a fault code 16 occurred unrelated to the reported complaint.However, the reported fault code16 error message could not be replicated during functional testing, and the probable cause could not be determined.The autopulse platform failed initial functional testing due to the ua45 error message displayed upon powering on, unrelated to the customer's reported complaint.The root cause of the ua45 advisory message was due to the driveshaft not being at the "home" position, likely attributed to user error.The driveshaft was rotated to the home position using the administrative menu to clear the ua45 error message.User advisory (ua) 45 is a clearable error message; per the autopulse® resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on, a user advisory 45 will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear the user advisory 45, pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.Following service, a brake gap inspection was performed and verified the brake gap was within the specification.The autopulse platform was subjected to a final run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15245168
• Report Number: 3010617000-2022-01160
• Device Sequence Number: 12214446
• Product Code: DRM
• UDI-Device Identifier: 00849111001113
• UDI-Public: 00849111001113
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-10
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown