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

Model Number 8700-0700

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 05/20/2014

Event Type  malfunction  

Event Description

It was reported that during patient use, the bottom (plastic part) of the autopulse lifeband became detached from the autopulse platform as it was being slid under the patient.Customer stated that the autopulse unit was being slid in sideways as this occurred.No adverse patient sequelae was reported.After the reported event, customer inspected all of the lifebands in their service.During their preliminary investigation, they found one lifeband installed onto a unit that had a defect or was broken.No further information was provided.

Manufacturer Narrative

Please see the following related mfr.Report #3003793491-2014-00390 for issue regarding the first autopulse® lifeband with sn: unknown.The autopulse lifeband in complaint was returned to zoll on 07/21/2014 for investigation.Investigation of the returned lifeband could not confirm the customer's reported issue of the lifeband being defective as visual evaluation found no issues or discrepancies with the unit.Functional testing was performed with the autopulse platforms and indicated that the unit performed as intended.

Manufacturer Narrative

Visual inspection for the returned unit revealed that the skirt hook did not catch the cam style tumbler, making the skirt loose on the roller.This would allow the "butterfly clip" to fall open.Investigation of the returned lifeband confirmed the customer's reported issue of the lifeband being defective.The root cause of the reported problem could not be determined.

Event Description

Additional clarification on the reported problem for the defective/damaged lifeband: customer found that the skirt hook "did not catch the cam style tumbler, making the skirt loose on the roller." customer indicated that this would allow the "butterfly clip" to fall open.

• 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: 3974700
• MDR Text Key: 17576909
• Report Number: 3003793491-2014-00391
• 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: 05/20/2014

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: 8700-0700
• Device Catalogue Number: 8700-0700
• Device Lot Number: 40749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 08/04/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2013
• 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