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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The autopulse platform (sn (b)(4)) was used in the non-traumatic shock room to resuscitate a male patient in cardiac arrest.The ongoing resuscitation was in place before the platform use.The platform stopped after performing 3 compressions.The platform was restarted, however, the customer was not able to resolve the issue and the platform stopped again after performing 3 compressions.The lucas device was used from the catheter lab to continue cpr.The patient's status information was requested but the customer did not provide a response.During the troubleshooting of the platform, the belt cover of the lifeband (lot# 179342) was observed torn and had disrupted operation since it had damage.Per the reporter, the autopulse battery was replaced and the lifeband was examined during the morning shift check.The lifeband was noted in good condition.Please see the following related mfr reports: mfr 3010617000-2023-00317 for autopulse platform (sn (b)(4)).
Additional Manufacturer Narrative
The reported secondary complaint that "the autopulse lifeband (lot # 179342) was observed torn was confirmed during the visual inspection of the returned lifeband.The probable root cause for the damaged lifeband was due to the partially twisted bands or excessive force applied to the protective cloth cover of the belt during lifeband resetting, attributed to user mishandling.Upon visual inspection, it was observed that the protective cloth cover on both bands was completely detached from the hinged belt guard by being forcibly ripped from its fixing point.No functional testing was performed due to the lifeband condition.However, the lifeband damage observed during the visual inspection did not affect the functionality of the lifeband as the bands were moving freely without any resistance.The autopulse user guide provides the following caution - make sure that the lifeband is not twisted before automatic compressions begin.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for the lifeband lot number 179342.

• Brand Name: AUTOPULSE® LIFEBAND
• Common Device Name: CARDIAC RESUSCITATOR BAND
• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16661317
• Report Number: 3010617000-2023-00318
• Device Sequence Number: 17793873
• Product Code: DRM
• UDI-Device Identifier: 00849111001588
• UDI-Public: 00849111001588
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0701-08
• Device Lot Number: 179342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown