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

Model Number MODEL 100

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

The lifeband involved in the reported complaint will not be returned for investigation because the customer has disposed of it.Therefore, physical investigation could not be performed, and the root cause could not be determined.

Event Description

The autopulse platform (sn (b)(6)) was used for resuscitating a patient.During the compressions, the crew needed to reset the lifeband by pulling up on it three times.After resetting the lifeband (lot #unknown) and upon resuming compressions, the lifeband broke, the drive shaft spun, and the autopulse platform displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message.Per the customer, the lifeband broke at the hinged belt guards of the lifeband cover plate.The crew reverted to manual cpr for the rest of the call.No consequences or impacts on the patient.After returning to the station, the crew couldn't rotate the drive shaft to its home position and felt that the drive shaft was stuck.Please see the following related mfr report: mfr 3010617000-2023-00798 for the autopulse platform.

• Brand Name: AUTOPULSE® LIFEBAND
• Type of Device: 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 nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17800031
• MDR Text Key: 324054661
• Report Number: 3010617000-2023-00854
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• 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: 8700-0701-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1