MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE®RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/29/2023 during device evaluation of the autopulse platform (sn (b)(6)), the platform failed functional testing upon powering up due to user advisory (ua) 45 (not at "home" position after power-on/restart).No patient involvement.
Additional Manufacturer Narrative
On 11/29/2023 during device evaluation of the autopulse platform (sn (b)(6)), the platform failed functional testing upon powering up due to user advisory (ua) 45 (not at "home" position after power-on/restart) error message.The root cause for the (ua) 45 error was due to the driveshaft not being at "home position." the error message can be easily cleared by pulling up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.However, in this case, the encoder driveshaft was difficult to rotate and exhibited binding and resistance.This might have caused difficulty for the user to pull up the lifeband completely prior to turning the device on.This was due to a drive train failure, possibly related to the age of the device.The autopulse platform was manufactured in 2015 and is 8 years old, past its expected service life of 5 years.Upon visual inspection, related to the error message, a cut autopulse lifeband was attached with the driveshaft.To correctly remove the lifeband, the driveshaft must be in the home position.The driveshaft issue likely prevented the user from pulling the lifeband straps completely up to reset the driveshaft.Therefore, the customer was unable to remove the lifeband and cut it.The autopulse platform failed initial functional testing due to the (ua) 45 error message displayed upon powering on.The drivetrain motor will be replaced to remedy the issue.Upon service completion, the console 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 was no previous history of complaints reported for autopulse platform with serial number (b)(6).
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: AUTOPULSE®RESUSCITATION SYSTEM
• Common Device Name: CARDIAC RESUSCITATOR, LINE-POWERED
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA
• 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: 18373374
• Report Number: 3010617000-2023-01056
• Device Sequence Number: 18069997
• Product Code: DRM
• UDI-Device Identifier: 00849111002530
• UDI-Public: 00849111002530
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 07/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: 100
• Device Catalogue Number: 8700-0740-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2015
• 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