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

Model Number 8700-0706-01

Device Problems Break (1069); Defective Device (2588); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2014

Event Type  malfunction  

Event Description

It was reported that the autopulse lifeband was defective.Part of the clip was broken and the lifeband was twisted.Customer indicated that the belt guards (black u-shaped plastic clips) on the sides of the lifeband did not "click" and snap into place on the metal post at either side of the lifeband.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 zoll on 11/03/2014 for investigation.Investigation results as follows: the lifeband was not received in its original packaging.The compression pad was received dirty with blood stains all over the top and bottom of the pads and belt guards.The reported issue of the lifeband being twisted was confirmed; inspection revealed multiple creases and twists on the surface of the belt guard.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.It appeared the unit had been used and these damages were due to wear and tear.Functional testing revealed that the right hinged skirt of the cover plate "snapped" into the retracted position.The hook caught the cam style tumbler securing the "butterfly clip" tightly.The left clip was broken and would not "snap" into the retracted position, thus confirming the reported complaint of the skirt hook not catching the cam style tumbler.With the condition of the unit as received being damaged and torn apart, additional functional testing with the test autopulse and mannequin could not be performed.The reported complaint was confirmed based on visual inspection of the left clip as well as the lifeband belt and compression pads.All lifebands are 100% inspected to ensure that there are no damages and that the clips function properly.Based on the condition of the returned unit, the cause of the damages observed to the lifeband have 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: 4130622
• MDR Text Key: 18367926
• Report Number: 3010617000-2014-00490
• 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: 09/05/2014

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: 8700-0706-01
• Device Catalogue Number: 8700-0706-01
• 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
• Initial Date Manufacturer Received: 12/30/2014
• Initial Date FDA Received: 09/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2014
• 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