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

Model Number 8700-0701

Device Problem Break (1069)

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

Event Date 12/25/2015

Event Type  malfunction  

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.

Event Description

The customer reported that during clinical use on a patient, part of the lifeband's belt clip broke.When the lifeband was removed from the platform, the autopulse stopped working.The crew reverted to manual cpr.There was not patient sequelae reported.No other information was provided.After the rescue activities were completed, the emergency response personal checked the platform and found a part of the broken piece stuck in the groove of the shaft.The crew removed the broken piece from the groove.

Manufacturer Narrative

The autopulse lifeband (s/n (b)(4)) was returned to zoll for evaluation.Dhr review for autopulse life band lot number 12394 found no nonconformities with the lot.A visual inspection of the returned lifeband was performed and found that the lifeband was received not on its original packaging.The compression pad was received dirty.Investigation of the life band indicated that the locking tabs located on the right and left cover/channel brace assembly were broken and would not "snap" into retracted position; thus confirming the reported complaint.Functional testing of the life band could not be performed because the broken locking tabs prevented the belt guards to lock in place.Note that the autopulse lifeband are 100% inspected during manufacturing.Zoll inspection procedure has steps to verify the hinge pin is in place and is flush with the surface of the belt guard and no twists or creases are present throughout the entire belt.The belt sections covered by (b)(6) are felt by hand to assure no twits exist.

• 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: 5435443
• MDR Text Key: 38228373
• Report Number: 3010617000-2016-00070
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• 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: 12394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2016
• 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