• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADAPTEC MEDICAL DEVICES LLC 3014271001 SENSICA UO MONITOR ICU

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ADAPTEC MEDICAL DEVICES LLC 3014271001 SENSICA UO MONITOR ICU Back to Search Results
Catalog Number SCCS1001
Device Problems Inadequate or Insufficient Training (1643); Defective Device (2588)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
 
Event Description
It was reported that the sensica device had a load cell issue.
 
Event Description
It was reported that the sensica device had a load cell issue.
 
Manufacturer Narrative
The reported was confirmed.The root cause of the reported issue was use-related, as the user improperly removed the patient ring causing the front face of the load cell to break off.The unit was evaluated upon receipt.Load cell assembly needs to be replaced.Per evaluation, the user improperly removed the patient ring causing the front face of the load cell to break off.No repairs were made, as the customer declined repair and requested the unit be sent back without service.As a part of field action, the following components were replaced/added per the latest revision of the bill of material for sensica icu, product code sccs1001 rev h base pcba,rev c sensica icu base pcba firmware, rev d sensica icu application software, rev a windows enterprise os, rev a power supply label.Product label , usb connection label, was replaced with the latest revision of the label (rev c) per the latest bill of material for sensica icu, product code sccs1001.Replaced pcba rev h with firmware - serial number (b)(4).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "to attach the ring to the sensica uo system stand, turn the ring upside down and use a clockwise motion to twist and "lock" the ring onto the ring interface.Do not apply excessive force or torque to the ring or the system's ring interface when connecting the device to avoid damaging components.Do not turn the ring counterclockwise when attaching it." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SENSICA UO MONITOR ICU
Type of Device
SENSICA
Manufacturer (Section D)
ADAPTEC MEDICAL DEVICES LLC 3014271001
260 james jackson avenue
cary NC 27513
MDR Report Key10095960
MDR Text Key193057822
Report Number1018233-2020-03482
Device Sequence Number1
Product Code EXS
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 12/17/2020
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 Catalogue NumberSCCS1001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2020
Initial Date Manufacturer Received 05/08/2020
Initial Date FDA Received05/28/2020
Supplement Dates Manufacturer Received12/02/2020
Supplement Dates FDA Received12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-