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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 Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2018
Event Type  Injury  
Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that the spiral tip of the fetal spiral electrode (989803137631) had broken. The baby required surgery to remove the tip and an overnight stay in the hospital.
 
Manufacturer Narrative
It was reported that a baby girl/¿patient¿ was born via ¿normal birth¿ and the doctor used the device before the delivery time for monitoring of the fetal heart. Philips was advised that during the birth, the doctor had trouble connecting the device to the infant's head and after repeated attempts, the device had been replaced. At birth, the hospital reportedly saw swelling and redness that they assumed was caused by the repeated attempts to connect the device. Two weeks later, the patient appeared at the emergency room and a metallic foreign body attached to the scalp was noticed. The object was removed by surgery and the patient was hospitalized for one day for observation philips inquired if the difficulty in connecting the device could have resulted in the electrode being over rotated, leading to breakage of the device¿s tip. The distributor responded that the doctor was unaware that the electrode broke, so he likely would not know how it broke. A return material authorization was issued for return of the device involved in the incident for evaluation. However, philips was advised that the hospital team was not aware of the occurrence of the broken electrode. Therefore, the device was not retained. Philips was also informed that the hospital does not have information about the device, batch or any other detail. Further information was requested related to this information, but an answer could not be provided. Philips is considering this a malfunction of cause unknown for reporting purposes only.
 
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Brand NameFETAL SPIRAL ELECTRODE
Type of DeviceFETAL 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 Key8270685
MDR Text Key133862798
Report Number1218950-2019-00656
Device Sequence Number1
Product Code HGP
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K030691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989803137631
Device Catalogue Number989803137631
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/20/2019
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? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/23/2019 Patient Sequence Number: 1
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