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

Model Number 8700-0706-01

Device Problems Bent (1059); Defective Device (2588); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2014

Event Type  malfunction  

Event Description

It was reported that the autopulse lifeband was defective.The clip was slightly bent.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 information was provided.

Manufacturer Narrative

Zoll has not yet received the autopulse lifeband in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The autopulse lifeband was returned to zoll on 11/03/2014 for investigation.Investigation results as follows: the lifeband was not received in its original packaging.The compression pad was received dirty with scuff marks and blood stains at the bottom of the compression pad.Further visual inspection of the returned unit revealed multiple creases and twists on the surface of the belt guard.It appeared the unit had been used and these damages were due to wear and tear.The reported complaint was not confirmed.Functional testing revealed that both right and left hinged skirts of the cover plate "snapped" into the retracted position.The hook caught the cam style tumbler securing the "butterfly clip" tightly.Both skirts snapped into place allowing the "butterfly clip" to tightly secure on the side slot of the autopulse.It should be noted that no issues were encountered when compression testing was performed with the returned lifeband for 10 minutes using a test autopulse platform and mannequin.The unit performed as intended.

• 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: 4130623
• MDR Text Key: 20858104
• Report Number: 3010617000-2014-00491
• 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