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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

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

Event Date 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

The autopulse li-ion battery involved in the reported complaint will not be returned to zoll for evaluation because the customer was able to resolve the issue by fully inserting the reported battery into the autopulse platform, and the battery functioned as intended.

Event Description

Initially, the customer reported that the autopulse li-ion battery (s/n unknown) failed to power up an autopulse platform.As per the customer, the battery had successfully passed charging in an autopulse multi-chemistry battery charger (mcc), and therefore, the battery was fully charged before inserting it into the platform.The customer stated that the autopulse was able to power up with no issues using other li-ion batteries.Based on the additional information received from the customer on 18 november 2021, the battery may have not been fully inserted into the autopulse.The customer tested the reported battery, and it has been functioning as intended.Therefore, the battery will not be returned to zoll for investigation.It is unknown where the problem occurred.However, patient use information was requested, but no additional information was provided.

Event Description

Initially, the customer reported that when the fully charged autopulse li-ion battery (s/n unknown) was inserted into an autopulse platform after use, the battery failed to power up the platform.The customer stated that the autopulse was able to power up with no issues using other li-ion batteries.Based on the additional information received from the customer on 18 november 2021, the battery may have not been fully inserted into the autopulse.The customer tested the reported battery, and it has been functioning as intended.Therefore, the battery was placed back into rotation and will not be returned to zoll for investigation.The customer was unable to recall the battery's serial number.No patient involvement.

Manufacturer Narrative

H6 (health effect - clinical code) was updated based on the received additional information.H6 (health effect - impact code) was updated based on the received additional information.

Event Description

Initially, the customer reported that when the fully charged autopulse li-ion battery (s/n (b)(6)) was inserted into an autopulse platform after use, the battery failed to power up the platform.The customer stated that the autopulse was able to power up with no issues using other li-ion batteries.Based on the additional information received from the customer on (b)(6) 2021, the battery may have not been fully inserted into the autopulse.The customer tested the reported battery, and it has been functioning as intended.Therefore, the battery was placed back into rotation and will not be returned to zoll for investigation.The customer was unable to recall the battery's serial number.No patient involvement.

Manufacturer Narrative

B5 (describe event or problem) was updated.D2 (common device name, serial #) was updated.H4 (device manufacture date) was updated.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: 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: 12957589
• MDR Text Key: 282493556
• Report Number: 3010617000-2021-01140
• 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: D163369
• 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,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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