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

Model Number 8700-0701-02

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was confirmed.The customer reported the lifeband became detached after performing compressions for a duration of 35 minutes.The evaluation of band 1 shows damage indicative of a twisted belt during use.Visual inspection was performed and noted no external damage upon receipt.However, after the white protective sleeve was removed from the band 1, a twisted belt was observed.In addition, unrelated to the reported complaint, one of the hinged belt guards found to be slightly loose and another one does not produce a clicking sound.Functional testing of the lifeband could not be performed because the band 1 had a twisted belt and bent hinge located on the covers/channel braces assembly prevented the belt guards from locking in place.The reported complaint could result from the band 1 twisted belt.During use, the lifeband could exert additional force to one side of the belt and disengage the velcro closure.The autopulse user guides warns the user to not strap across, or otherwise constrain, the lifeband.Constraining the movement of the lifeband can damage or break the lifeband.Additionally, the user guide also provides the following caution - make sure that the lifeband is not twisted before automatic compressions begin.

Event Description

During patient use, the customer reported the lifeband was detached after performing compressions for a duration of 35 minutes.No additional information was provided.No consequences or impact to patient was reported.

• 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: 8465491
• MDR Text Key: 140484950
• Report Number: 3010617000-2019-00227
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001595
• UDI-Public: 00849111001595
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0701-02
• Device Catalogue Number: 8700-0701-02
• Device Lot Number: 79831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2018
• 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