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

Model Number 989803137631

Device Problem Break (1069)

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

Event Date 09/03/2018

Event Type  Injury  

Manufacturer Narrative

Unable to confirm serial number.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 (b)(4) had broken.The tip of the (b)(4) fetal spiral electrode was removed from the baby's scalp.

Manufacturer Narrative

The product did not perform as expected by the customer.A replacement product was ordered and sent to the customer.No product was available for evaluation, therefore we are considering this to be a malfunction of unknown cause.The reported problem could not be confirmed.

• 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 Key: 7893352
• MDR Text Key: 120846545
• Report Number: 1218950-2018-07435
• Device Sequence Number: 1
• Product Code: HGP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K030691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 989803137631
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2018
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA
• Patient Weight: 4