MAUDE Adverse Event Report: ZOLL CIRCULATION, INC LIFEBAND® LOAD-DISTRIBUTING BAND; CARDIAC RESUSCITATOR BAND

Model Number	100
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the autopulse lifeband (lot unknown) was not retracting or compressing the patient.The crew discontinued use of the autopulse platform (sn 32561) and reverted to manual cpr.No additional information was provided.Patient's status information was requested but the customer did not provide a response.
Additional Manufacturer Narrative
Zoll has not received the autopulse lifeband in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
The customer reported the autopulse lifeband (lot unknown) was not retracting or compressing the patient.The crew discontinued use of the autopulse platform (sn (b)(6) and reverted to manual cpr.The customer did not observe any error messages.No impact or consequence to the patient.
Additional Manufacturer Narrative
B5 (describe event or problem), h6 (adverse event problem), and h11 (provide narrative/ data were updated based on the customer response.The lifeband involved in the reported complaint will not be returned for evaluation because the customer has disposed of it.Therefore physical investigation could not be performed and the root cause could not be determined.

• Brand Name: LIFEBAND® LOAD-DISTRIBUTING BAND
• Common Device Name: CARDIAC RESUSCITATOR BAND
• 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
• MDR Report Key: 21063502
• Report Number: 3010617000-2025-00049
• Device Sequence Number: 19652660
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: 8700-0701-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown