MAUDE Adverse Event Report: ZOLL CIRCULATION 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	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
During shift checks, the autopulse platform (sn (b)(6)) keeps displaying user advisory (ua) 45 (not at "home" position after power-on/restart).The customer attempted to clear the advisory message by returning the driveshaft to "home" position, following the administrative menu more than once.However, the ua45 appears again the day after it is cleared.No patient involvement.
Additional Manufacturer Narrative
D9 (returned to manufacturer) was updated.H4 (device manufacture date) was updated.The reported complaint that the autopulse platform (sn (b)(6)) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) was confirmed in the archive data and during functional testing.The root cause of the ua45 advisory message was that the driveshaft was not in "home" position, most likely attributed to unintended user error.Upon visual inspection, no physical damage was observed.The archive data review indicated multiple ua45 advisory messages around the reported event date, confirming the customer's reported complaint.A user advisory is normally a clearable error message, and it is designed into the autopulse platform to alert the operator that autopulse has detected one of several conditions.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 a 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.Preliminary functional test failed as the autopulse platform displayed a ua45 advisory message upon powering up, confirming the reported complaint.The driveshaft was rotated to "home" position to remedy the ua45 advisory message.Subsequently, the autopulse platform successfully passed multiple run-in tests.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the 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; 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: 18414838
• Report Number: 3010617000-2023-01092
• Device Sequence Number: 2748501
• 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,Followup
• Report Date (Section B): 07/24/2024

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: 8700-0740-10
• 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: 12/07/2023
• Supplement Date Received by Manufacturer: 12/07/2023; 07/22/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 02/02/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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