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

Model Number	MODEL 100
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the autopulse li-ion battery (sn unknown) is stuck in 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 not received the autopulse li-ion battery in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.
Additional Manufacturer Narrative
B5 (describe event or problem) was updated.D4 (serial #) was updated.D9 (returned to manufacturer) was updated.H4 (device manufacture date) was updated.H6 codes were updated.The reported complaint of the autopulse li-ion battery (sn (b)(6)) being stuck in the autopulse platform (sn (b)(6)) was confirmed during visual inspection.The root cause for the reported complaint was the damaged/ broken latch of the autopulse li-ion battery, likely caused by mishandling such as a drop.During further visual inspection, no other physical damage was observed.The battery's status leds showed one flashing red light, as the battery was stuck in the platform without being charged.A review of the battery's archive data showed 31 successful condition and charge cycles over its lifetime, and it was last charged successfully on february 10, 2024.No errors or anomalies were found in the archive.Functional testing was not attempted due to the broken battery latch.
Event or Problem Description
The customer reported that the autopulse li-ion battery (sn (b)(6)) is stuck in 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.

• 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19038839
• Report Number: 3010617000-2024-00336
• Device Sequence Number: 18263467
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/13/2024

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: MODEL 100
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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