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

Model Number	MODEL 200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released as it is exempt from premarket submission.Zoll has not received the autopulse nxt band for investigation.A follow-up report will be submitted if and when the product is returned, and the investigation has been completed.
Event or Problem Description
The customer reported that while inserting the nxt band pins into the autopulse nxt platform slot, it felt like the pins went in further than they should have.The customer mentioned that the pins on two nxt bands (lot #unknown) were slightly offset compared to those on the functioning nxt bands.Additionally, the customer noted that the bands may have been inserted incorrectly.The customer had not experienced similar issues with the other nxt bands, as those pins appeared even and not offset.The reported problem occurred during the training session.No patient involvement.
Event or Problem Description
The customer reported that while inserting the nxt band pins into the autopulse nxt platform slot, it felt like the pins went in further than they should have.The customer mentioned that the pins on two nxt bands were slightly offset compared to those on the functioning nxt bands.Additionally, the customer noted that the bands may have been inserted incorrectly.The customer had not experienced similar issues with the other nxt bands, as those pins appeared even and not offset.The reported problem occurred during the training session.No patient involvement.
Additional Manufacturer Narrative
Additional information in d4 (lot #) and h4 (device manufacture date).The customer's complaint on the autopulse nxt band (lot #206848) was not confirmed during the visual inspection and functional testing.During testing, the nxt band pins functioned appropriately and as intended.Functional testing of the returned nxt band was performed using a known good autopulse nxt platform, and the nxt band pins were placed into the slot without any issues.

• Brand Name: LIFEBAND® LOAD-DISTRIBUTING BAND
• Common Device Name: CARDIAC RESUSCITATOR, LINE-POWERED
• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 21599075
• Report Number: 3010617000-2025-00188
• Device Sequence Number: 9035234
• Product Code: DRM
• UDI-Device Identifier: 10849111002988
• UDI-Public: 10849111002988
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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): 08/08/2025

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: MODEL 200
• Device Catalogue Number: 8700-001013
• Device Lot Number: 206848
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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