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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FETAL SPIRAL ELECTRODE; FETAL SPIRAL ELECTRODE, SINGLE

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PHILIPS MEDICAL SYSTEMS FETAL SPIRAL ELECTRODE; FETAL SPIRAL ELECTRODE, SINGLE Back to Search Results
Model Number 989803137631
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.We are still in the process of assessing the incident.The electrodes were discarded.
 
Event Description
The customer reported they could not remove the fetal electrode probe from the infant's scalp.Emergent care was provided by the doctor and the tip was removed from the infant's scalp and discarded.
 
Manufacturer Narrative
The customer reported an intern could not remove the fetal electrode probe from the infant's scalp and that this was the intern's third time having this problem.The attending physician cut the baby's scalp in order to remove the fetal spiral electrode.The fetal spiral assembly was discarded and not available for evaluation.As the result of this event, the customer was provided training on the use of the fetal spiral electrode by a philips representative.It was observed that the intern was applying the electrode with more than one turn and the plastic tip was embossing into the baby¿s scalp.As a result, we are not considering this to be a product malfunction.The ifu for the fse (p/n (b)(4) states in a warning not to over rotate the fse.The date of the incident was not provided.
 
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Brand Name
FETAL SPIRAL ELECTRODE
Type of Device
FETAL SPIRAL ELECTRODE, SINGLE
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
robert corning
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key7070368
MDR Text Key93322848
Report Number1218950-2017-08087
Device Sequence Number1
Product Code HGP
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K030691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number989803137631
Device Lot Number171291
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/20/2017
Initial Date FDA Received11/30/2017
Supplement Dates Manufacturer Received11/20/2017
Supplement Dates FDA Received03/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age1 DA
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