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

Model Number MODEL 100

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2024

Event Type  malfunction  

Event 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.

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.

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 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
• 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19038839
• MDR Text Key: 339322340
• Report Number: 3010617000-2024-00336
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2024

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
• 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
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• 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