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

Model Number MODEL 102

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2020

Event Type  malfunction  

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 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
• Type of Device: CARDIAC RESUSCITATOR BAND
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10041026
• MDR Text Key: 193122968
• Report Number: 3010617000-2020-00485
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 10849111002247
• UDI-Public: 10849111002247
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: MODEL 102
• Device Catalogue Number: 8700-0706-14
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 05/08/2020
• 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: Initial
• Patient Sequence Number: 1