MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE LI-ION BATTERY; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	MODEL 200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: pma/510(k): premarket submission number not available/not released.Zoll has not received the autopulse nxt lithium-ion battery in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
During patient use, the finger ring of the autopulse nxt battery (sn (b)(6) got broken.The customer stated that the battery's finger ring was sticking in the partially unlocked position when changed out during patient use, not allowing the autopulse to remain on.Therefore, manual cpr was provided to the patient until the batter's finger ring was rotated and placed in the lock position.No malfunction was reported on the autopulse nxt platform, and it was put back in service.No consequences or impacts on the patient.
Additional Manufacturer Narrative
Sections d9 and h4 were updated.The reported complaint that the finger ring of the autopulse nxt battery (sn 01476) broke was confirmed during visual inspection.The root cause of the complaint was a weak spot in the finger ring locking mechanism, which caused the finger ring to rotate past the lock/unlock mark.Upon visual inspection, the finger ring assembly was broken but still attached to the battery, confirming the reported complaint.Archive review was not performed due to physical damage.The functional test was not performed due to physical damage.

• Brand Name: AUTOPULSE LI-ION BATTERY
• 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: 20268511
• Report Number: 3010617000-2024-00815
• Device Sequence Number: 17970912
• Product Code: DRM
• UDI-Device Identifier: 00849111002998
• UDI-Public: 00849111002998
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: MODEL 200
• Device Catalogue Number: 8700-001012
• 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: 09/11/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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