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

Model Number	100
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the autopulse li-ion battery (sn unknown) is stuck and cannot be removed from the autopulse platform (sn (b)(6).No further information was provided.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.
Additional Manufacturer Narrative
Zoll has received the autopulse li-ion battery for investigation.A follow-up report will be submitted when the investigation has been completed.
Event or Problem Description
The customer reported that the autopulse li-ion battery (sn (b)(6)) is stuck and cannot be removed from the autopulse platform (sn (b)(6)).No further information was provided.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.
Additional Manufacturer Narrative
Additional information in b5 (describe event or problem), d4 (serial #) and h4 (device manufacture date).The customer's complaint that the autopulse li-ion battery (sn (b)(6)) is stuck and cannot be removed from the autopulse platform (sn (b)(6)) was confirmed during the visual inspection.During a visual inspection, it was noted that the battery was stuck in the autopulse platform due to a broken finger latch on the battery.The probable root cause of the broken finger latch was user mishandling.The functional testing of the returned battery could not be performed due to a broken latch.

• Brand Name: AUTOPULSE LI-ION BATTERY¿
• Common Device Name: SECONDARY BATTERY
• 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 ; 4084192347
• MDR Report Key: 20348755
• Report Number: 3010617000-2024-00774
• Device Sequence Number: 20816057
• Product Code: DRM
• UDI-Device Identifier: 00849111001847
• UDI-Public: 00849111001847
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: 100
• Device Catalogue Number: 8700-0752-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2021
• 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