MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PREATTACHED LEADWIRE ELECTRODE, SQUARE; PREWIRED NEONATAL ECG ELECTRODE

Model Number 13953A

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

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 02/20/2017

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that a (b)(6) neonate in an incubator incurred 3rd degree burns on the lower left side of the body (confirmed by a dermatologist).Philips 13953a electrodes were being used to monitor the infant.

Manufacturer Narrative

The philips 13953a electrodes used during the reported incident were not returned to philips for evaluation because they were disposed of by the customer.While there is no available information to suggest that the philips 13953a electrodes were being used incorrectly, there are indications of possible use error related to a transcutaneous gas transducer.The open incubator (ge) was heated to about 26 degrees and used as a bed only.There was no skin prep or lotion used on the infant and no issues with the other two leads (ra and la).The infant¿s position could not be confirmed.Emergent care could not be confirmed.None of this information provides additional insight as to the cause of the reported incident.On two occasions, philips ((b)(4)) requested additional information about the reported issue from the customer, but did not receive a response.The investigation into this incident did not reveal any information that suggested or supported that a product malfunction was the cause for the patient response.The customer requested further information for the electrode, for example: ifu update, test results, coo, bom of the electrode 13953a (especially the materials composing the gel part), any chemical burn cases reported globally and any technical data to guarantee that the electrode cannot cause a chemical burn.The customer requested that the electrode be tested by a local independent test agency.However, the particular tests requested by the customer could not be performed.Biocompatibility tests were requested by the customer for the electrode 13953a (irritation, cytotoxicity and sensitization).All testing passed.The customer still did not accept this information and suggested that the cause of the issue was still unknown and not user error.In response, the customer requested more tests on the electrode.Further discussions were held with the customer about this testing and it was decided not to proceed with the testing.Two philips clinical product specialists reviewed the picture of the patient¿s response.During these reviews, it was noted that the footprint of the impacted area resembled the footprint of a transcutaneous gas transducer (m1918a/b).The cause of this incident is most consistent with one of/or a combination of the following scenarios: transcutaneous gas transducer was left on the patient for an extended period, transcutaneous gas transducer¿s temperature was set inappropriately high, transcutaneous gas transducer was repeatedly reapplied to the same location.The ifu/user setup instructions show the footprint for the fixation ring/transducer.In addition, the area under the transducer head (center of the ring) is the area that will be affected by heat generated by the transducer while performing measurements.The philips 13953a electrodes do not generate energy.Therefore, they cannot lead to burns related to electrical current.Biocompatibility testing of the electrodes demonstrated no issues.Labeling updates were made for customer satisfaction purposes, but the customer stated that they did not feel that the product¿s labeling was the cause of the patient¿s response.The patient monitor¿s ifu (453564496611, revision a) states on page 288: warning prolonged continuous monitoring may increase the risk of undesirable changes in skin characteristics, such as irritation, reddening, blistering or burns.If the site timer is disabled, the transducer will heat indefinitely while on a patient.Change the site regularly, in accordance with medical procedures in your hospital.Based on the available information, we are considering this incident to be related to clinical application/use error of the transcutaneous gas transducer.There is no evidence supporting that the product failed to work as intended or failed to meet specifications.No customer response was requested.Philips korea has provided the customer with information throughout the duration of the investigation.The customer has agreed that the case can be closed without further corrective action.The electrodes that were used, were disposed of by the customer.

• Brand Name: PREATTACHED LEADWIRE ELECTRODE, SQUARE
• Type of Device: PREWIRED NEONATAL ECG ELECTRODE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6427195
• MDR Text Key: 70635178
• Report Number: 1218950-2017-01806
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K871412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 13953A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 21 DA
• Patient Weight: 4