MAUDE Adverse Event Report: ZOLL CIRCULATION 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	06/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product 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 the shift check, the fully charged autopulse li-ion battery (sn 10997) will not power on the autopulse platform.The status indicator of the battery showed four green lights, indicating that the battery is fully charged.No patient involvement.
Additional Manufacturer Narrative
The customer reported a complaint that " the fully charged autopulse li-ion battery (sn (b)(6) is unable to power on the autopulse platform" was confirmed during functional testing but not during the archive review.The possible root cause for the reported complaint could not be determined.Upon visual inspection, no physical damage was observed.The status leds of the battery illuminated four steady green lights.The autopulse li-ion battery successfully charges in a known good autopulse multi-chemistry battery charger (mcc).The status leds on the battery showed four steady green lights.However, when the fully charged battery is inserted into a known good autopulse platform, the battery was unable to power on the platform, thus confirming the reported complaint.Based on the archive review, the battery was first inserted into a charger on (b)(6) 2022.Charging attempts were all successful from that date through the end of the archive - (b)(6) 2022.The last charge was on (b)(6) 2022.There are multiple in_out indications on (b)(6) 2022 - where the battery was inserted and removed from a device - possibly the autopulse platform.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Common Device Name: LI-ION BATTERY, RECHARGEABLE
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 14871062
• Report Number: 3010617000-2022-00803
• Device Sequence Number: 6976801
• Product Code: MOQ
• UDI-Device Identifier: 00849111001915
• UDI-Public: 00849111001915
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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: 8700-0752-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• 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