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

Model Number 8700-0701-01

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2019

Event Type  malfunction  

Manufacturer Narrative

The autopulse lifeband in complaint was disposed by the customer and it will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if and when the lifeband is returned and investigation has been completed.

Event Description

The autopulse platform (sn (b)(4)) was used on a 80 year old female patient weighing 350 lbs.Approximately 10 mins.During compression the lifeband started to tear and twist and the autopulse stopped compression and autopulse displayed "realign patient".The crew performed troubleshooting steps by re-aligning the patient multiple times, however the platform stopped each time after performing several compressions.The use of the autopulse was discontinued and manual cpr was performed.No patient consequence.Additional information: per reporter the lifeband was disposed.See mfr 3010617000-2019-00296 for the issue with autopulse platform (sn (b)(4)).

• 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: 8457843
• MDR Text Key: 140171755
• Report Number: 3010617000-2019-00297
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2019
• 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
• Patient Age: 80 YR
• Patient Weight: 159