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

Model Number MODEL 100

Device Problem Battery Problem (2885)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

The li-ion battery in the complaint has not been returned for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

The customer reported the autopulse li-ion battery (sn (b)(6)) would not power on the autopulse platform.Then, the battery would not charge in the multi-chemistry battery charger (mcc).The status led on the battery is blinking red, indicating that the battery failed and cannot be used in the autopulse platform.The battery was tested in two different mccs, but the battery still would not charge.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.

Manufacturer Narrative

B5 (describe event or problem) and h6 (adverse event problem) was corrected.The customer reported a complaint that "the autopulse li-ion battery (sn (b)(6) would not power on the autopulse platform" was confirmed during the functional testing.The archive data could not be retrieved, and a review was not performed.Without being able to reset the internal microprocessor and access the archive files, the root cause of the reported battery failure could not be determined through this investigation.However, the probable root cause for the reported complaint could be due to battery mismanagement and charging practice or electrostatic discharge (esd) or broken/damaged components or a battery - charger communication failure.Also, battery failure due to an issue with the multi-chemistry battery charger could not be ruled out.Upon visual inspection, no physical damage was observed, and the status leds of the battery did not illuminate.The battery failed to charge in a known good autopulse multi-chemistry battery charger (mcc).The status leds of the battery did not illuminate after the charging event.The status leds on the mcc showed a red "fail" led indication.Therefore, the battery also cannot be used in the autopulse platform.Requested the customer to send the autopulse multi-chemistry battery chargers (mcc) to zoll for investigation.

Event Description

During shift check, the customer reported the autopulse li-ion battery (sn (b)(6) would not power on the autopulse platform.The multi-chemistry battery charger indicated the battery was charged.The color of the status leds on the battery is unknown.Then, after the battery failed in the platform, the battery would not charge in the multi-chemistry battery charger (mcc).The status leds on the charger indicated the red "fail" x.The status led on the battery is blinking red, indicating that the battery failed and cannot be used in the autopulse platform.The battery was tested in two different mccs, but the battery still would not charge.No patient involvement.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: 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: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17062612
• MDR Text Key: 316596204
• Report Number: 3010617000-2023-00478
• Device Sequence Number: 1
• Product Code: MOQ
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1