MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LIFEBAND; CARDIAC RESUSCITATOR BAND

Model Number	MODEL 100
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Retraction Problem (1536)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
When the customer first installed the lifeband (lot #unknown) on the autopulse platform for patient use, the lifeband became loose and did not retract properly.The patient was supposedly positioned correctly.The customer does not know which error message has occurred.The customer discarded the lifeband and switched to manual cpr.The patient's status information was requested, but the customer did not provide a response.The customer's biomedical engineer inspected the autopulse platform used at the time of the event but did not find any issues with the platform.The biomedical engineer tested the autopulse platform with another lifeband, but the issue was not replicated.
Additional Manufacturer Narrative
The customer discarded the lifeband involved in the reported complaint.Therefore, a physical investigation could not be performed by zoll, and the root cause could not be determined.

• Brand Name: AUTOPULSE® LIFEBAND
• Common Device Name: CARDIAC RESUSCITATOR BAND
• 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: 19667919
• Report Number: 3010617000-2024-00508
• Device Sequence Number: 6918004
• Product Code: DRM
• UDI-Device Identifier: 00849111001588
• UDI-Public: 00849111001588
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0701-08
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/03/2024
• 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