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

Model Number MODEL 100

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the lifeband was stuck on the driveshaft of the autopulse platform was confirmed during visual inspection.The complete lifeband was not returned.However, part of the lifeband was attached to the autopulse platform drive shaft.Noticed that the lifeband belt was cut and the lifeband clip was left on the drive shaft.The root cause of the stuck lifeband was due the seized clutch and drive shaft of the autopulse platform.

Event Description

During patient use, the autopulse platform (sn (b)(4)) stopped compression and displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message.In addition, the lifeband belt was stuck on the drive shaft.Following this, the platform was replaced to continue patient care.Patient's status information was requested but the customer did not provide a response, therefore patient's status is unknown.Please see the following related mfr report: mfr # 3010617000-2021-00366 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 nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 11766904
• MDR Text Key: 249274920
• Report Number: 3010617000-2021-00365
• 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: 05/03/2021

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: 04/05/2021
• Initial Date FDA Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1