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

Model Number MODEL 100

Device Problem Retraction Problem (1536)

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

Event Type  malfunction  

Manufacturer Narrative

The lifeband associated with this complaint was discarded by the user.Since the device was not returned, an investigation could not be performed and a root cause could not be determined.

Event Description

The autopulse platform (s/n (b)(4)) was used to resuscitate a patient in cardiac arrest.The ems crew turned on the autopulse, pulled up on the lifeband (lot # unknown), and pressed the green start/continue button to start chest compressions.However, the lifeband was not retracted, and the platform displayed the prompt: "initializing".The ems crew checked the lifeband alignment and found no issues.The crew pulled up the lifeband again and re-pressed the green start/continue button; however, the issue persisted.The ems crew switched to manual cpr and transported the patient to an emergency room (er) with rosc (return of spontaneous circulation).The er staff cut the lifeband to easily remove the patient from the platform and continued with manual cpr.No consequences or impact to the patient.After the call, the autopulse platform was tested multiple times.No issues were found, and the prompt could not be replicated.Please see the following related mfr report: mfr # 3010617000-2021-00663 for the autopulse platform (s/n (b)(4)).

• 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: 12257268
• MDR Text Key: 264461337
• Report Number: 3010617000-2021-00664
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2021
• 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: 07/05/2021
• 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