MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS

Model Number M1333A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death, Intrauterine Fetal (1855)

Event Date 10/07/2016

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.(b)(6).

Event Description

The customer reported that an incident (death of a patient) occurred while a m1333a koala tip catheter was in use.It has not been confirmed yet that if the device malfunctioned or if the device was a contributing factor the patient¿s death.

Manufacturer Narrative

The customer reported that, after the placenta localization, the clinician introduced the product without any resistance following the procedure of the user guide.Within a half of a minute of insertion of the product, the baby reportedly went into a bradycardia condition.The patient was within 9 minutes at the operating room for a cesarean where the baby was born after 15 minutes, but the baby had died.There reportedly was a lesion at the placenta because of the product.Philips clinical evaluation of the information made available by the hospital was performed.Philips¿ clinical opinion, the lesion was likely located in the umbilical vein (not placental vein), based on the timing of the events (bradycardia within 30 seconds).The lesion was likely caused by the iupc (intrauterine pressure catheter) device.The most reasonable conditions that would lead to an umbilical vein lesion by the iupc device are device-related (hard iupc tip) or application-related (failure to follow ifu).The available information does not support that either of these conditions were present during this incident.Therefore, it is not known why the iupc caused the lesion in the umbilical vein.As a result, we are considering this to be a malfunction for reporting purposes only.

Manufacturer Narrative

The customer reported that, after the placenta localization, the clinician introduced the product without any resistance following the procedure of the user guide.Within a half of a minute of insertion of the product, the baby reportedly went into a bradycardia condition.The patient was within 9 minutes at the o.R.Room for a cesarean where the baby was born after 15 minutes, but the baby had died.There reportedly was a lesion at the placenta because of the product.Philips clinical evaluation of the information made available to philips by the hospital was performed.Philips¿ clinical opinion is that the lesion was likely located in the umbilical vein (not placental vein as previously reported), based on the timing of the events (bradycardia within 30 seconds).It is possible that the lesion could have been caused by the iupc (intrauterine pressure catheter) device, but the possibility that the lesion was caused by other means could not be ruled out.According to philips¿ supplier of this product, the two conditions could possibly lead to an umbilical vein lesion by the iupc device are either device-related (hard iupc tip) or application-related (failure to follow ifu).The available information does not support that either of these conditions were present during this incident.Therefore, if the iupc device caused the lesion in the umbilical vein, it is not known why or how this occurred.As a result, we are considering this to be a malfunction for reporting purposes only.

• Brand Name: NA
• Type of Device: NA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6270846
• MDR Text Key: 65520798
• Report Number: 1218950-2017-00523
• Device Sequence Number: 1
• Product Code: HGS
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: M1333A
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Weight: 5