MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE LI-ION BATTERY¿; SECONDARY BATTERY

Model Number	100
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the autopulse li-ion battery for investigation.A follow-up report will be submitted when the product is returned, and the investigation has been completed.
Event or Problem Description
During patient use, the customer reported the autopulse platform sn (b)(6) powered off after 10 seconds when the battery sn (b)(6) was used.The crew was not sure if any warning messages were displayed.The crew immediately switched to manual cpr.Following the insertion of the second battery in the autopulse platform, the device continued compressions without any issues.No consequences or impact to patient.After the call, the first battery sn (b)(6) was tested, showing green blinking lights when the status button was pressed.
Additional Manufacturer Narrative
The reported complaint of the autopulse li-ion battery (sn (b)(6)) powering off the autopulse platform after 10 seconds was not confirmed during the functional testing and the archive data review.No device malfunction was observed during the testing, and the battery worked as intended.Based on the archive review, the battery (sn (b)(6)) was not used on the platform during the reported event.The archive data review showed no errors recorded around the customer's complaint date.During functional testing, the battery successfully powers on a known good autopulse platform multiple times without any fault or error.The battery passed charging several times in a known good autopulse multi-chemistry battery charger, and the status leds of the battery showed four green lights flashing each time as designed.The battery was manufactured in december 2020 and is more than three years old.

• Brand Name: AUTOPULSE LI-ION BATTERY¿
• Common Device Name: SECONDARY BATTERY
• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 19935502
• Report Number: 3010617000-2024-00652
• Device Sequence Number: 14675133
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/20/2024

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: 8700-0752-01
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2020
• 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