MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS EFFICIA CM150; COMPACT PORTABLE PATIENT MONITORS

Model Number 863322 EFFICIA CM150

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

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Customer reported that the m1193a spo2 sensors (efficia cm150) are burning the patients in the nicu.

Manufacturer Narrative

The symptom reported was a small redness.The customer removed the device from the affected limb and treated the lesion according to their clinical protocol.No action was necessary to prevent loss of motor function because the injury was minimal.The incident was reviewed by the product development team, expert engineers, product managers and clinical specialists.A technical team was referred to the institution and collected more information about the clinical use of the product, they opened a new sensor to demonstrate how they were using the sensor and appeared it to be correct.According to the information available, it is not possible to say that there is a problem with the led of the device, because the sensor continued to be used after adjustments made by the customer and the problem was not repeated.The intensity of light emission by the led does not vary according to the position in which it is installed.The sensors do not exceed 41 ° c when used in environments with temperatures up to 35° c.Root cause analysis indicates that the reported failure may be related to the method of use and / or installation of the sensors, as well as the clinical condition of the patient.

Event Description

Customer reported that the m1193a spo2 sensors (efficia cm150) are burning the patients in the nicu.The efficia cm has never been sold or marketed in the usa.The efficia cm150 (b)(4) (863322) is substantially similar to efficia cm150 global (863304).

• Brand Name: EFFICIA CM150
• Type of Device: COMPACT PORTABLE PATIENT MONITORS
• 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: 8945309
• MDR Text Key: 155978398
• Report Number: 1218950-2019-06509
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K052707
• 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: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863322 EFFICIA CM150
• Device Catalogue Number: 863066
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 08/15/2019
• Supplement Dates FDA Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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