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

Model Number MODEL 100

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

The lifeband (lot # 158335) used at the time of the event will not be returned for evaluation, as it was discarded by the customer.Therefore, a physical investigation could not be performed and a root cause could not be determined.

Event Description

The lifeband (lot # 158335) was used to resuscitate a patient in cardiac arrest.Before installing the lifeband to the autopulse platform, the user checked the proper alignment of the lifeband, and no twist was observed.After autopulse platform was powered on, no compressions were performed because the lifeband got twisted.Per the customer, the autopulse platform did not display any error messages.The user re-started the autopulse 3 or 4 times and continued to use the autopulse, but the issue persisted.In addition, the user stated that sometimes the lifeband ragged.No death or injury was reported.No consequences or impact to the patient.

• 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: 12346371
• MDR Text Key: 267441691
• Report Number: 3010617000-2021-00758
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 10849111001691
• UDI-Public: 10849111001691
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• 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: 8700-0706-01
• Device Lot Number: 158335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2021
• 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