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

Model Number	MODEL 200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
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.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common injury such as skin injury is expected adverse event for both manual and mechanical cprs.The aha guidelines emphasized the importance of high-quality chest compressions and recommends ensuring adequate compression rates and depth.Skin injury is common but acceptable consequence of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.Based on available information, the event of skin injury was serious since it was reported as severe.Due to location and the time point, the event of skin injury was causally related to the autopulse device and the procedure.The event was not related to device deficiency.
Event or Problem Description
The customer reported an incident recently occurred with the autopulse platform (sn unknown) and autopulse lifeband (lot unknown) where a patient with an increased bmi sustained severe bl flank pressure injuries secondary to the straps of the device.Because of the patient's increased bmi, the straps were too tight around their trunk circumference.Due to this, the straps dug into the patient's flanks causing severe degradation of the skin.No additional information was provided.Patient's status information was requested but the customer did not provide a response.
Additional Manufacturer Narrative
B5 (describe event or problem), d4 (additional device information), and g4 (premarket identification) were corrected.Per the customer follow up response, the autopulse nxt system was used instead of the autopulse (legacy) system.For g4: pma/510(k): premarket submission number not available/not released.
Event or Problem Description
The customer reported an incident recently occurred with the autopulse nxt platform (sn unknown) and autopulse nxt band (lot unknown) where a patient with an increased bmi sustained severe bl flank pressure injuries secondary to the straps of the device.Because of the patient's increased bmi, the straps were too tight around their trunk circumference.Due to this, the straps dug into the patient's flanks causing severe degradation of the skin.No additional information was provided.Patient's status information was requested but the customer did not provide a response.

• 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: 22733600
• Report Number: 3010617000-2025-00529
• Device Sequence Number: 8884772
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MODEL 200
• Device Catalogue Number: 8700-001013
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/18/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown