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

Model Number 8700-0701-01

Device Problems Retraction Problem (1536); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

The report of the lifeband cover plate was separated from the bottom of the platform was not confirmed based on the functional testing of returned lifeband.Visual inspection was performed and noted no damage upon receipt.Functional testing was performed and the lifeband was subjected to the installing and removing process with the same autopulse platform for approximately five times and it functioned as intended.

Event Description

During the autopulse platform deployment for patient use, the lifeband cover plate was separated from the bottom of the platform.Manual cpr was immediately performed on the patient.Rosc (return of spontaneous circulation) was achieved.The crew was able to get the cover plate properly installed back on the autopulse platform and the platform was placed under the patient during the transport in case the patient will require the cpr.The platform was not deployed during the call, however, the crew noticed the lifeband cover plate has detached again when the platform was removed under the patient.No consequences or impact to patient.After the call, the autopulse platform was tested one more time with the lifeband and the issue could not be duplicated.

• 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: 8542270
• MDR Text Key: 142858983
• Report Number: 3010617000-2019-00334
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• 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: 87317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2019
• 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