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

Model Number 8700-0701

Device Problems Defective Device (2588); Mechanics Altered (2984)

Patient Problem No Patient Involvement (2645)

Event Date 02/09/2015

Event Type  malfunction  

Event Description

It was reported that during training, the autopulse lifeband was observed to be defective.One side is short and the other side is long.The lifeband was ripped by the platform due to one side being shorter.There was no patient involvement.No further information was provided.

Manufacturer Narrative

Product in complaint was returned to zoll on 02/20/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

Please note that a correction was made to device available for evaluation, as the autopulse lifeband in complaint was returned to the manufacturer on 2/24/2015 not 2/20/2015 as indicated on the initial report.The lifeband was not received in its original packaging.The compression pad was received dirty.Further visual inspection for the returned unit revealed multiple creases and twists on the surface of the belt guard indicating that the unit was used multiple times.The rub guard liner that connects to the top compression pad of the left belt guard cap was completely torn, ripped and broke apart from the cover plate.The butterfly clip hinge was found broken.The unit appeared to have been used until it failed.No other issues were observed.Dimensional investigation was performed.The customer reported event could not be confirmed.Current specification is 30.50 +/-.25" from belt clip tail/belt clip foot.Overall dimension should be 66.50 +/-.25".Considering the condition of the unit upon receipt, the overall length of the returned unit was measured at 65.50" which is within specification limit.

• 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: 4561325
• MDR Text Key: 5455192
• Report Number: 3010617000-2015-00133
• Device Sequence Number: 1
• Product Code: DRM
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8700-0701
• Device Catalogue Number: 8700-0701
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2015
• 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