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

Model Number MODEL 100

Device Problem Fitting Problem (2183)

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

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

The lifeband with this complaint was not returned for evaluation.The product was disposed by the customer.Since the device was not returned, an investigation could not be performed and a root cause could not be determined.

Event Description

During patient use, the lifeband band clip had broken off and preventing the hinged belt guard of the lifeband (lot #unknown) from snapping in place to the autopulse platform.The autopulse platform (sn (b)(4) displayed user advisory "(ua)12" (lifeband not present) error message.The customer performed 20-30 manual cpr and rosc was achieved at the hospital.Back at the station, a new lifeband (lot #175571) was also noticed with the same issue while just snapping the band clip off and on.The lifeband used on a patient was disposed and the lifeband used at the station was returned for evaluation.No consequences or impact to the patient.Please see the following related mfr report: mfr (b)(4) for the autopulse platform (sn (b)(4).Mfr (b)(4) for the lifeband (lot #175571).

• 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 nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15786127
• MDR Text Key: 304353709
• Report Number: 3010617000-2021-02013
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• 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: 11/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2022
• 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: 10/17/2022
• 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