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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VITALCONNECT VITALPATCH BIOSENSOR WIRELESS PHYSIOLOGICAL MONITOR, PRODUCT CODE:DRG

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VITALCONNECT VITALPATCH BIOSENSOR WIRELESS PHYSIOLOGICAL MONITOR, PRODUCT CODE:DRG Back to Search Results
Model Number 3012-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ulceration (2116)
Event Date 08/31/2017
Event Type  Injury  
Manufacturer Narrative
The device was returned for analysis, and a visual inspection did not reveal any anomalies with the device. A review of the data provided by the customer indicated that the device was functional for its intended duration. A review of the manufacturing records did not identify any discrepancies that could be related to the reported issue. A review of manufacturing records identified that the same patient contacting adhesive lot has been used in the manufacture of (b)(4) lots for a total of (b)(4) devices. Additionally, the same lot of patient contact hydrogel has been used in (b)(4) lots dating back to may 2016 (date of device manufacture). The complaint files were reviewed and there has been one other report of a skin ulceration originating from the same customer using the same lot of devices. There have been no other similar complaints from other customers or for other device lots. The customer was asked to provide the labeling that accompanied the device in the investigational study, which was provided and reviewed. Upon review, it was identified that the customer generated instructions for device application are not consistent with the device manufacturer's instructions for use. More specifically, the customer instructs the use of cavilon no sting barrier film prior to the application of the device. None of the clinical wear validations conducted by the manufacturer have evaluated the device compatibility with cavilon. Based on this information, failure to follow instructions was identified as the root cause.
 
Event Description
Subject had applied the device on (b)(6) 2017 and in the evening started having a burning sensation, irritating the skin a little bit. The symptoms went away. Upon removal on (b)(6) 2017, the subject noticed that the area under the battery side was raw and had broken skin. The patient did not seek medical attention for this skin ulceration; the situation resolved on its own.
 
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Brand NameVITALPATCH BIOSENSOR
Type of DeviceWIRELESS PHYSIOLOGICAL MONITOR, PRODUCT CODE:DRG
Manufacturer (Section D)
VITALCONNECT
224 airport parkway
suite 300
san jose CA 95110
Manufacturer (Section G)
VITALCONNECT
224 airport parkway
suite 300
san jose CA 95110
Manufacturer Contact
shari rideout
224 airport parkway
suite 300
san jose, CA 95110
MDR Report Key6898653
MDR Text Key87593434
Report Number3010830833-2017-00002
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152139
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,study
Reporter Occupation
Type of Report Initial
Report Date 09/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/02/2017
Device Model Number3012-01
Device Catalogue Number3012-01
Device Lot Number06117401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/27/2017 Patient Sequence Number: 1
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