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

Model Number 8700-0701

Device Problems Device Inoperable (1663); Material Twisted/Bent (2981)

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

Event Date 12/11/2014

Event Type  malfunction  

Event Description

Complainant alleged that during patient use, the autopulse® lifeband became twisted after performing approximately 3 minutes of compressions, which caused the autopulse to stop and the device was unable to be used for the remainder of the call.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 the manufacturer for evaluation.The reported complaint of the lifeband becoming twisted was confirmed during visual inspection.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.The rub guard liner that connects to the top compression pad of the left belt guard cap was severely twisted, torn and ripped apart from the cover plate.No other issues were observed.Potential causes for the customer's reported issue may have been due to an anomaly during autopulse deployment, resulting from user handling of the device beyond its parameters of use (i.E.The lifeband was twisted during compressions, and/or the unit might have been used more than once).The autopulse user guide (p/n 12555-001), instructs the user to "lift up the lifeband to its fullest extension, ensuring that the side bands are at a 90 degree angle to the platform, that they are not twisted and there are no obstructions".The user guide also states "do not strap across, or otherwise constrain, the lifeband.Constraining the movement of the bands can damage or break the lifeband".

• 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: 4378078
• MDR Text Key: 5119196
• Report Number: 3010617000-2015-00003
• 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,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2014

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: 50330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 01/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2015
• 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