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

Model Number 8700-0701-24

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

Complainant alleged that during training, it was observed that the belt guard clip of the autopulse lifeband was broken.There was no report of any patient involvement.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 lifeband was not received in its original packaging.No dirt was noted.The unit appeared to have been used multiple times.Functional testing revealed that the right hinged skirt of the cover plate would not "snap" into retracted position.The hook did not catch the cam style tumbler securing the "butterfly clip" tightly.The right skirt would not snap into place allowing the "butterfly" clip to fall open into the side slot of the autopulse, thus confirming the reported complaint.However, 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 during functional testing.All lifebands are 100% inspected to ensure that there are no damages and that the clips function properly.Based on the condition of the unit, the cause of the right clip not opening and closing properly has been determined to be handling damage sustained during use or storage.

• Brand Name: AUTOPULSE® LIFEBAND
• Type of Device: CHEST COMPRESSION ASSEMBLY
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4362746
• MDR Text Key: 5263540
• Report Number: 3010617000-2014-00669
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2014

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: 8700-0701-24
• Device Catalogue Number: 8700-0701-24
• Device Lot Number: 12878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 12/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2015
• 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