MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LIFEBAND; CHEST COMPRESSION ASSEMBLY

Model Number 8700-0706-01

Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2014

Event Type  malfunction  

Event Description

Complainant alleged that the autopulse® lifeband was defective.Customer indicated that the belt guards (black u-shaped plastic clips) on the sides of the lifeband did not "click" and snap into place on the metal post at either side of the lifeband.No adverse patient sequelae was reported.No further details were provided.

Manufacturer Narrative

Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Manufacturer Narrative

The autopulse lifeband was returned to the manufacturer for analysis.The lifeband was not received in it's original packaging.The compression pad was received dirty.Further inspection of the returned unit revealed multiple creases and twists on the surface of the belt guard, indicating that the unit was used.The rub guard liner that connects to bottom of the compression pad of the right belt guard cap, was completely torn apart and ripped.It appeared that the unit had been used and the damage was due to wear and tear.Functional testing revealed that both hinged skirts of the cover plate would not "snap" into the retracted position.The hook did not catch the cam style tumbler securing the "butterfly clip" tightly.Since the condition of the returned unit was torn and ripped; additional functional testing using a test autopulse and mannequin could not be performed.Visual inspection of the clips revealed that both the hook and hinge pin on both the left and right skirts had been bent out of position.Based on the condition of the unit, the cause of the left and right clips not opening and closing properly, has been determined to be handling damage sustained during use or storage.

• Brand Name: AUTOPULSE® LIFEBAND
• Type of Device: CHEST COMPRESSION ASSEMBLY
• 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: joy patel ; 2000 ringwood ave; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4130704
• MDR Text Key: 4943538
• Report Number: 3010617000-2014-00487
• Device Sequence Number: 1
• Product Code: DRM
• 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: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0706-01
• Device Catalogue Number: 8700-0706-01
• Device Lot Number: 47156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2014
• 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