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

Model Number 8700-0701

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

Complainant alleged that the autopulse® lifeband was defective.The lifeband tab was 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 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 zoll for analysis.The lifeband was not received in its original packaging.The compression pad was received dirty with some unknown stain marks at the top and bottom pads.Further inspection of the returned unit revealed multiple creases and twists on the surface of the belt guard indicating that the unit was used.No other issues were observed.The reported complaint could not be confirmed.Visual inspection of the clips revealed that both the hook and hinge pin on the right and left skirt are in good working condition.Functional testing revealed that both hinged skirts of the cover plate "snapped" into the retracted position.The hook caught the cam style tumbler securing the "butterfly clip" tightly.It should be noted that when compression testing was performed with the returned lifeband for 10 minutes using a test autopulse platform and mannequin, no issues were encountered.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: 4130669
• MDR Text Key: 4794428
• Report Number: 3010617000-2014-00489
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0701
• Device Catalogue Number: 8700-0701
• Device Lot Number: 12846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2014
• Initial Date FDA Received: 09/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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