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

Model Number	MODEL 100
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
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
The customer advised that during shift check, the led lights on the multi-chemistry battery charger (mcc) were green, indicating the autopulse li-ion battery (sn (b)(6)) is fully charged.When the battery is taken out of the charger and the test button was pressed and all four leds blink green 6 times and then go out.However, the battery will not power the autopulse platform.The platform performs as intended with other batteries.No patient involvement.
Additional Manufacturer Narrative
The reported complaint that the autopulse li-ion battery (sn (b)(6) will not power the autopulse platform was not confirmed during the archive data review or functional testing.The battery was functional and works as intended.Upon visual inspection, no physical damage was observed, and the status leds of the battery showed four flashing green lights.The archive data indicated 35 successful charge cycles over the battery's lifetime.On (b)(6) 2021, unrelated to the reported complaint, the battery encountered an over-current fault, but subsequently recovered.The last successful charge occurred on (b)(6) 2024.The battery passed charging in a known good autopulse multi-chemistry battery charger (mcc).The status leds on the battery showed four solid green lights after the successful charging attempt, indicating a fully charged battery that surpassed 3 years from its date of manufacture.The battery was able to successfully power an autopulse platform for over 30 minutes.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Common Device Name: LI-ION BATTERY, RECHARGEABLE
• 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 ; 4084192922
• MDR Report Key: 19397445
• Report Number: 3010617000-2024-00416
• Device Sequence Number: 6955739
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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 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: 04/30/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2021
• 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