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	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the autopulse platform (sn (b)(6)) overheated during the patient call.The area where the lifeband connected became very hot and there was a burning smell.In addition, the autopulse li-ion battery (sn (b)(6)) depleted fast during this incident.Per the reporter, the platform was on the black ems trap, placed on the stretcher during the incident and the stretcher needed to be stationary to start compressions.The patient was over 6 feet tall and around 300 lbs.The customer did not observe any abnormalities with the lifeband band during the use.The battery is changed every 24 hours with a 3-battery rotation schedule.No consequences or impact to the patient.
Additional Manufacturer Narrative
Zoll has not received the autopulse li-ion battery in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Additional Manufacturer Narrative
The customer reported the autopulse li-ion battery (sn (b)(6)) depleted fast during the call 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.No physical damage was observed and one amber light was flashing on incoming inspection.The archive data review showed no errors in the whole archive.The battery was last charged successfully on september 21, 2021, which is the last event logged in the archive.Over the battery's lifetime, 115 successful charge cycles were documented.The battery passed charging in a known good autopulse multi-chemistry battery charger, and the status leds of the battery showed four green lights.The battery was successfully tested on the customer's autopulse platform using a large resuscitation text fixture and performed compression for over 35 minutes without any faults.

• 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: 19736352
• Report Number: 3010617000-2024-00527
• Device Sequence Number: 12542059
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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: 06/14/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• 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
• Patient Weight: 300 KG