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

Model Number	100
Medical Device Problem Codes	Use of Device Problem (1670); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, the autopulse platform involved in the complaint was not removed from service after the incident and was used again shortly after.The autopulse platform has been functioning properly since then.Therefore, the customer has decided not to return the autopulse platform to zoll for investigation.
Event or Problem Description
Upon being dispatched to a cardiac arrest at a residence, the customer deployed the autopulse platform (sn (b)(6) to provide automated cpr to the patient.After delivering five compressions, the autopulse stopped, displaying a message of "realign patient" and "pull up lifeband".The crew realigned the patient, ensuring the yellow identification marker was visible under the patient's armpit, but the autopulse would not restart.Despite four more attempts to adjust the lifeband and inspect the patient's positioning, the lifeband failed to retract and function.Consequently, the ems crew reverted to manual cpr.No consequences or impacts on the patient.After the call, the customer inspected the autopulse platform and lifeband, which revealed no visible damage or issues.The customer mentioned that the issue might have been due to user error or a problem with the lifeband, but it's difficult to determine since the lifeband used at the time was discarded.

• 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 20778681
• Report Number: 3010617000-2024-00943
• Device Sequence Number: 13019850
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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: 8700-0740-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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