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	04/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse lifeband associated with this complaint was not returned for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
During the patient use, the platform displayed user advisory (ua) 02 (compression tracking error) error.The lifeband was noted twisted intermittently during the operation.The user reinstalled the lifeband to make sure it is properly installed, however, the issue persists.The crew immediately reverted to manual cpr.No consequences or impact to patient.The platform was tested back at the station and was confirmed to perform as intended with the new lifeband.Per a reporter, the lifeband with the issue was installed on the platform for about a month.Please see the following related mfr report: mfr 3010617000-2020-00484 for autopulse platform.

• Brand Name: AUTOPULSE® LIFEBAND
• Common Device Name: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10041026
• Report Number: 3010617000-2020-00485
• Device Sequence Number: 2812726
• 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,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2020

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: UNKNOWN
• 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: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1