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

Model Number	MODEL 102
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the lifeband involved in the reported complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
The autopulse platform (sn: (b)(4)) was used to treat a patient in cardiac arrest.The patient was placed on the platform, and the compressions were performed for almost 30 minutes.Then, the platform stopped compressions and displayed user advisory (ua) 02 (compression tracking error) error message.As reported, the lifeband (lot # 143423) kept getting twisted intermittently, and the issue was observed 2 or 3 times during the use of the platform.The user tried to clear the error multiple times, but the issue was not resolved.No consequences or impact to patient.Please see the following related mfr report: mfr # 3010617000-2020-00482 for the autopulse platform (sn: (b)(4)).

• Brand Name: AUTOPULSE® LIFEBAND
• Common Device Name: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10030438
• Report Number: 3010617000-2020-00483
• Device Sequence Number: 3881160
• Product Code: DRM
• UDI-Device Identifier: 10849111002247
• UDI-Public: 10849111002247
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/06/2020

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 102
• Device Catalogue Number: 8700-0706-14
• Device Lot Number: 143423
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1