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

Model Number 989803137631

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2016

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.The patients were twins (mfr report# 1218950-2016-02176 addresses patient 1 and mfr report# 1218950-2016-02177 addresses patient 2).

Event Description

It was reported that the fetal monitor provided inaccurate fetal heart rate measurement data.It was reported that the infants required emergent care was necessary (intubation and incubation).

Manufacturer Narrative

There was no material returned for evaluation.According to the hospital risk manager, the product was discarded before risk management was made aware of the incident.When asked if it was being considered that the patient issues were the direct result of the delay in acquiring ecg signals / monitoring of the infants, the hospital risk manager reported that the troubleshooting time delayed monitoring of the patient, but that the delay in monitoring was not determined to be the result of a philips product failure.The product involved in the incident was discarded by the customer.There is no indication that the product malfunctioned.The hospital risk manager indicates that a philips representative visited their facility and provided a review/training of the use of the fetal spiral electrodes with 71 hospital staff members and that there have been no further issues/incidents since this incident.

Event Description

The customer indicated that they were unable to acquire fetal heart rate via the (b)(4) fetal spiral electrodes (fse) due to difficulty in deploying the fses.The customer indicated that the infant had apgar scores of 1,3,5.It was reported that the infant required emergent care.It was reported that the infant required emergent care (resuscitation, intubation, body cooling for 3 days with morphine drip for comfort).The infant also reportedly suffered 2 seizures (confirmed via eeg monitoring) and required treatment with phenobarbital to control the seizures.The patient was reportedly discharged before 10 days of life with ¿good outcome¿.It was reported that ongoing outpatient follow-up is being performed to assess for developmental issues.

• 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: richa shah ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 5569882
• MDR Text Key: 42412415
• Report Number: 1218950-2016-02177
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 989803137631
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA
• Patient Weight: 3