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

Model Number	100
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A zoll territory manager reported that the eval autopulse platform sn (b)(6) does not turn on anymore.The platform has been tested with different autopulse li-ion batteries but the outcome was always the same.There is no visible damage to the power button.The platform was being operated by zoll personnel at the time of the failure.No patient involvement.
Additional Manufacturer Narrative
The autopulse platform in the complaint has not been returned for investigation.Therefore, a physical investigation has not been performed.If the device is received for investigation/evaluation, the ccr will be re-opened.
Additional Manufacturer Narrative
The reported complaint of the eval autopulse platform (sn (b)(6)) does not turn on was not confirmed during functional testing.The reported complaint was not reproduced.The autopulse platform functioned as intended.Upon visual inspection, unrelated to the reported complaint, the backlight of the display flickers briefly when switched on and is dark afterwards.The root cause was a processor board failure, likely attributed to the device's aging.The autopulse platform was manufactured in 2013 and is 10 years old, past the expected service life of 5 years.The processor board was replaced to address the issue.Also unrelated to the reported complaint, the power distribution board (pdb) was out of date.The pdb was replaced to remedy the issue.The archive data review showed user advisory (ua) 16 (timeout moving to take-up position) error message, unrelated to the reported complaint.The autopulse platform passed the initial functional testing without any fault or error.The autopulse platform was tested with four autopulse li-ion batteries without any fault or error.The customer reported complaint and (ua) 16 observed in the archive could not be reproduced.User advisory is normally a clearable error message and is designed into the autopulse platform to alert the operator that autopulse has detected one of several conditions.Per the battery hangtag - advisory codes description and action, user advisory 16 is an indication that there is obstruction between the lifeband and patient, or a twisted lifeband.The recommended actions to take for this type of user advisory are: open lifeband, clear obstruction or twist, pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.
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 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: 17959765
• Report Number: 3010617000-2023-00897
• Device Sequence Number: 7007064
• Product Code: DRM
• UDI-Device Identifier: 00849111001090
• UDI-Public: 00849111001090
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,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: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 11/02/2023; 07/22/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/02/2023; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2013
• 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