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

Model Number 8700-0701

Device Problems Break (1069); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Complainant alleged that a spare autopulse lifeband was observed to be damaged.The lifeband clips did not clip properly and the lifeband material was torn near the clip.There was no report of any patient involvement.No further details were provided.Please note that the date of event was not 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 analysis.The autopulse lifeband was returned to the manufacturer for analysis.The lifeband was not received in it's original packaging.The compression pad was dirty and the left belt guard cover was found ripped and detached from the skirt, thus confirming the reported issue of the lifeband being torn near the clip.It appeared the unit had been used and this damage was due to wear and tear.Functional testing revealed that the left hinged skirt of the cover plate "snapped" into the retracted position.The hook caught the cam style tumbler securing the "butterfly clip" tightly.The right skirt however, would not snap into place allowing the "butterfly" clip to fall open into the side slot of the autopulse, thus confirming the reported issue of the clips not operating properly.It should be noted that when compression testing was performed, with the returned lifeband for 10 minutes with a test autopulse platform and mannequin, no issues were encountered.The unit performed as intended and the lifeband stayed in place during compression testing.Visual inspection of the clips revealed that both the hook and hinge pin on the right skirt had been bent out of position.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; 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: 4215842
• MDR Text Key: 5154313
• Report Number: 3010617000-2014-00575
• 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: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• 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: 40749
• 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: 12/19/2014
• 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