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

Model Number MODEL 100

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

The lifeband used at the time of the event was not returned to zoll for investigation.A follow-up report will be filed if the product is returned and investigation has been completed.

Event Description

During patient use, the autopulse platform [sn: (b)(4)] displayed user advisory (ua) 12 (lifeband not present) error message upon powering up.The use of the autopulse platform was immediately discontinued.No further information was provided by the customer.Patient's status information was requested, but the customer did not provide a response; therefore, patient's status is unknown.After the call, during device inspection, it was noted that the lifeband clip was broken.The lifeband was replaced; however, the autopulse platform still displayed the ua12 error message.Please see the following related mfr report: mfr # 3010617000-2021-00212 for the autopulse platform [sn: (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 nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 11500079
• MDR Text Key: 240369189
• Report Number: 3010617000-2021-00213
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/17/2021
• 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