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

Model Number 8700-0701-01

Device Problem Positioning Failure (1158)

Patient Problem No Patient Involvement (2645)

Event Date 06/22/2017

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.Additionally, per event information the lifeband was used on the autopulse platform (sn (b)(4)) at the time of the event.The platform was returned and evaluated under mfr 3010617000-2017-00497).

Event Description

It was reported that the autopulse platform (sn (b)(4)) displayed a user advisory (ua) 16 (timeout moving to take-up position) error message (the report of the platform displaying a ua 16 error message is reported under mfr 3010617000-2017-00497) and the autopulse lifeband did not retract.According to the user, the lifeband was pulled up and the platform was restarted; however, the issue did not resolve.No patient was involved with this event.No further information was provided.This report references the report of the lifeband unable to retract.

• 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: 6721460
• MDR Text Key: 80310566
• Report Number: 3010617000-2017-00556
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8700-0701-01
• Device Catalogue Number: 8700-0701-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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