MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS; NEO/INFANT/ADULT DISPOSABLE SP02 SENSOR

Model Number M1133A

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Date 12/03/2012

Event Type  Injury  

Manufacturer Narrative

Initial reporter: phone number not provided.Serial number not provided.A follow-up report will be submitted upon completion of the investigation.At this time, there is indication of user error.The application site is too large or becomes too large due to edema, excessive pressure may be applied.This can result in venous congestion distal from the application site, leading to hypoxemia and tissue malnutrition.Skin irritations or lacerations may occur as a result of the sensor being attached to one location for too long.

Event Description

It was reported that during deployment for use of the m1133a neonatal-infant-adult disposable spo2 sensor the customer stated that product "scalded" the patient (child).

Manufacturer Narrative

The investigation could not definitively confirm whether the device caused or contributed to the reported adverse event.Additional information was requested regarding the reported incident, but no response was received.Additionally, a return materials authorization (rma) form was sent for return of the product to philips.However, no material has been received for evaluation.The product¿s ifu states that, at elevated ambient temperatures, ¿patient skin could be severely burned after prolonged sensor application at sites that are not well perfused¿.The ifu instructs the user to check patient application sites frequently to prevent this condition.The ifu further describes that the sensors operate without risk of exceeding 41° c on the skin if the initial skin temperature does not exceed 35° c.Due to lack of response to requested additional information, it cannot be confirmed that this scenario occurred.As a result, we are considering this a malfunction of unknown cause.

• Brand Name: NA
• Type of Device: NEO/INFANT/ADULT DISPOSABLE SP02 SENSOR
• 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: 7428891
• MDR Text Key: 105406686
• Report Number: 1218950-2018-03222
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: KO52377
• 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: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: M1133A
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1