MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE® LIFEBAND; CARDIAC RESUSCITATOR BAND

Model Number MODEL 100

Device Problem Retraction Problem (1536)

Patient Problem Insufficient Information (4580)

Event Date 09/18/2023

Event Type  malfunction  

Event Description

Patient #2.During patient use on (b)(6) 2023, the customer reported the autopulse platform (sn unknown) displayed "reposition patient" message.This occurred on two calls with separate crews and seems to be a persistent issue.No adverse effects reported.Upon further investigation, the customer determined the issue was due to a faulty lifeband (lot unknown) which was not retracting properly.The customer installed a new lifeband and tried it out on a cpr mannequin and platform and new lifeband performed as intended.Please see the following related mfr reports: mfr #3010617000-2023-00921 for the autopulse platform (patient #2), mfr #3010617000-2023-00926 for the autopulse platform (patient #1), mfr #3010617000-2023-00927 for the lifeband (patient #1).

Manufacturer Narrative

Zoll has not received the autopulse lifeband in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

Additional information was provided, b5 (describe event or problem) was updated.

Event Description

Patient #2 during patient use on 9/18/23, the customer reported the autopulse platform (sn (b)(6)displayed "reposition patient" message.The crew switched to manual cpr.Manual cpr was performed for 25 minutes.This occurred on two calls with separate crews and seems to be a persistent issue.No adverse effects reported.Upon further investigation, the customer determined the issue was due to a faulty lifeband (lot unknown) which was not retracting properly.The customer installed a new lifeband and tried it out on a cpr mannequin and platform and new lifeband performed as intended.

• Brand Name: AUTOPULSE® LIFEBAND
• Type of Device: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17941186
• MDR Text Key: 326129889
• Report Number: 3010617000-2023-00892
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0701-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• 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: Unknown
• Patient Sequence Number: 1