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	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that "the fully charged autopulse li-ion battery (sn (b)(4)) didn't power up the autopulse platform" was not confirmed during functional testing performed at zoll.The status indicator on the battery showed one flashing red led when received by zoll service.A flashing red light indicates that the battery is permanently disabled and cannot be used in an autopulse platform.During visual inspection, no physical damage or anomalies were observed.The battery's archive was downloaded and reviewed at zoll to help verify the reported complaint.In february 2022, an "oz_wdt deadman" error occurred after charging.This is a charger-battery communication error, but it had no effect and did not cause damage to the battery.The battery was last successfully charged on 21 january 2023 with four solid green leds, several days prior to the customer's reported event date.Around february 2023, another "oz_wdt deadman" error occurred when removing the battery from the charger.This error resulted in the internal clock advancing more than 100 years into the future.One amber led was shown on the battery at that time, indicating that the battery was not fully charged.After the customer placed the battery into the charger, it passed the charging stages but was disabled by the charger because of the incorrect date on the battery's internal clock.The battery failed to charge in a known-good autopulse multi-chemistry battery charger (mcc) because the battery was already disabled upon receipt.The status leds on the mcc showed a fail "x" (red led) light, indicating that the charger could not charge the battery.The status leds on the battery still showed one flashing red light after the charging attempt.
Event or Problem Description
The customer reported that the fully charged autopulse li-ion battery (sn (b)(4)) didn't power up the autopulse platform.No further information was provided.The autopulse platform powered up properly with another autopulse li-ion battery.No patient involvement.

• 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: 16406242
• Report Number: 3010617000-2023-00184
• Device Sequence Number: 6279305
• Product Code: MOQ
• UDI-Device Identifier: 00849111065054
• UDI-Public: 00849111065054
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2023

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: 8700-0752-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2020
• 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