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

Model Number 8700-0701-01

Device Problem Malposition of Device (2616)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2014

Event Type  malfunction  

Event Description

Complainant alleged that when the autopulse was checked on (b)(6) 2014, it was observed that the left belt guard clip would not snap into place.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Manufacturer Narrative

The autopulse lifeband in complaint was returned and evaluated.Visual inspection showed no physical damages to the lifeband, including the lifeband clips.The lifeband was connected to a test autopulse platform and no issues were observed.The reported complaint of the clips not attaching could not be confirmed.The platform was also run with the returned lifeband on a test mannequin with no issues observed.

• 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: 4141351
• MDR Text Key: 19401362
• Report Number: 3010617000-2014-00505
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/10/2014

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: 8700-0701-01
• Device Catalogue Number: 8700-0701-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 10/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2014
• 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