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

Model Number 8700-0701-03

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the lifeband for investigation.A supplemental report will be filed when the product is returned and the investigation has been completed.Please see the following related mfr report: mfr # 3010617000-2019-00015 for the autopulse platform.

Event Description

As reported, during shift check, the lifeband was unable to be installed to the autopulse platform ((b)(4)).No patient involvement.

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 8236451
• MDR Text Key: 133125164
• Report Number: 3010617000-2019-00016
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065016
• UDI-Public: 00849111065016
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0701-03
• Device Catalogue Number: 8700-0701-03
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2018
• 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