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

Model Number 8700-0706

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2014

Event Type  malfunction  

Event Description

It was reported that during a customer site visit, a zoll autopulse deployment specialist found 6 defective autopulse lifebands.The lifebands were found to have "skirts" (hinged belt guards) that were in the closed position (flipped down) on at least one side and not both.When the belt guards were opened (flipped up), there were no clicking sounds and the "skirt" would not hold in the "up" position.No patient involvement 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.Please see the following related mfr.Reports: #3010617000-2014-00542 for autopulse® lifeband #1 with sn: unknown, #3010617000-2014-00543 for autopulse® lifeband #2 with sn: unknown, #3010617000-2014-00544 for autopulse® lifeband #3 with sn: unknown, #3010617000-2014-00547 for autopulse® lifeband #4 with sn: unknown, #3010617000-2014-00549 for autopulse® lifeband #6 with sn: unknown.

Manufacturer Narrative

The autopulse lifeband in complaint was returned to zoll on 11/03/2014 for investigation.Investigation results as follows: the lifeband was not received in its original packaging.It was received dirty with yellow stains on the compression pad.It appeared to have been used.The reported complaint could not be duplicated.Functional testing revealed that the left and right 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 no issues were encountered when compression testing was performed.A test autopulse platform ran for 10 minutes using the returned lifeband and a 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: 4200815
• MDR Text Key: 21724487
• Report Number: 3010617000-2014-00548
• 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,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0706
• Device Catalogue Number: 8700-0706
• 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: 11/14/2014
• 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