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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NEUROCOM SMART EQUITEST
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NATUS MEDICAL INCORPORATED NEUROCOM SMART EQUITEST Back to Search Results
Model Number A102884-00
Device Problems Break (1069); Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/31/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Event summary (product and patient/user/environment effect): natus technical service was contacted by the customer who reported a patient fall.Based on the information provided on the safety questionnaire from the customer.The event occurred on (b)(6) 2020.The patient fell through the wall screen, but did not have a serious injury, and did not fall to the floor.Technical service received an e-mail from customer who reported the patient was not wearing a harness during testing.Risk management file review: (b)(4) rev.M, i.D.E.35, severity score 3 is moderate and the risk rating is medium.
 
Event Description
The customer reported that a patient fell and the visual surround panel was broken.The patient fell through the wall screen, but did not have a serious injury, and did not fall to the floor.The patient was not wearing a harness at the time of the event.
 
Event Description
The customer reported that a patient fell and the visual surround panel was broken.The patient fell through the wall screen, but did not have a serious injury, and did not fall to the floor.The patient was not wearing a harness at the time of the event.
 
Manufacturer Narrative
Follow up report 002 (ref natus complaint #(b)(4)) technical service received e-mail from customer who reported the smart equitest balance performed as expected and the patient had no cuts or abrasions.Patient did have ecchymosis/swelling on left dorsal hand and left lower lip.The left dorsal hand and the left lower lip were treated with ice for 10 minutes and patient had recovered by (b)(4) 2021.Patient reported a "knot" at left hip, denied bruising, and reported it was improving.Customer reported she used the harness for certain patient populations but did not use it consistently on all patients because it seemed she received a more true test result without it.She would use the harness on all patients in the future.Page 21:neurocom balance manager system instructions for use: dynamic system states: during testing the patient must wear a harness connected by two suspension straps to the overhead bar.Harness straps must be tight enough to prevent injury should the patient fall,but loose enough to prevent the patient's movement from being restricted.Product examination and functional testing: product examination and functional testing were not performed by natus because the smart equitest balance performed as expected and did not malfunction.Capa and complaint trending review: there are no capa's related to this issue and this complaint does not identify a deficiency in the product design and therefore a capa is not required.Per qms-004442 complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.No complaint trends have been identified.Risk management file review doc-007348 rev.M, i.D.E.35, severity score 3 is moderate and the risk rating is medium.Risk review: a risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probability of occurrence has not changed.Dhr review: a dhr review is not applicable because prior to the reported issue the device was in service for 2 or more years and a manufacturing defect is very unlikely.Service record review: a search for service data that may have been relevant to this issue was conducted.No further information related to this issue was found.Investigation result code: failure to follow instructions.Complaint verified, isolated incident and monitor for future occurrence.
 
Manufacturer Narrative
05 feb 2021: (ref natus complaint # (b)(4)).Technical service received e-mail from customer who reported the smart equitest balance performed as expected and the patient had no cuts or abrasions.Patient did have ecchymosis/swelling on left dorsal hand and left lower lip.The left dorsal hand and the left lower lip were treated with ice for 10 minutes and patient had recovered by (b)(6) 2021.Patient reported a "knot" at left hip, denied bruising, and reported it was improving.Customer reported she used the harness for certain patient populations but did not use it consistently on all patients because it seemed she received a more true test result without it.She would use the harness on all patients in the future.Page 21:neurocom balance manager system instructions for use: dynamic system states: during testing the patient must wear a harness connected by two suspension straps to the overhead bar.Harness straps must be tight enough to prevent injury should the patient fall,but loose enough to prevent the patient's movement from being restricted.Product examination and functional testing: product examination and functional testing were not performed by natus because the smart equitest balance performed as expected and did not malfunction.Capa and complaint trending review: there are no capa's related to this issue and this complaint does not identify a deficiency in the product design and therefore a capa is not required.Per qms-004442 complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.No complaint trends have been identified.Risk management file review: doc-007348 rev.M, i.D.E.35, severity score 3 is moderate and the risk rating is medium.Is risk review required: a risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probability of occurrence has not changed.Dhr review: a dhr review is not applicable because prior to the reported issue the device was in service for 2 or more years and a manufacturing defect is very unlikely.Service record review: a search for service data that may have been relevant to this issue was conducted.No further information related to this issue was found.
 
Event Description
The customer reported that a patient fell and the visual surround panel was broken.The patient fell through the wall screen, but did not have a serious injury, and did not fall to the floor.The patient was not wearing a harness at the time of the event.
 
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Brand Name
NEUROCOM SMART EQUITEST
Type of Device
NEUROCOM SMART EQUITEST
Manufacturer (Section D)
NATUS MEDICAL INCORPORATED
5900 first avenue south
seattle, wa 98108 WA
MDR Report Key11135393
MDR Text Key231796977
Report Number3018859-2021-00001
Device Sequence Number1
Product Code GWQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 12/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberA102884-00
Device Catalogue NumberA102884-00
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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