MAUDE Adverse Event Report: MITG -GALWAY INVOS; OXIMETER, TISSUE SATURATION

Model Number	CNN/SNN
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the sensor caused a 0.5cm x 0.5 cm burn on the frontal area of a premature patient.
Additional Manufacturer Narrative
One cnn/snn sensor with lot number: ad1701031023 was received.The sensor was visually examined for any anomalies.It was observed that the sensor was returned with part of the sensor stuck to the cable and the patient side liner not reattached to the sensor.The sensor should be returned flat and with its patient side liner to prevent damage during shipping.A failure investigation (fi) 5100c invos monitor was connected to ac power.The ac power led illuminated.The fi monitor was powered on and passed power on self-test (post).The fi monitor was tested for proper operation using a fi 5100c pre-amplifier and was observed to operate as specified.The sensor was connected to the fi preamplifier and the fi test-bed device.The sensor failed with the following error message 'poor signal quality' coming up on the display screen and no rso2 values could be obtained.A root cause for the poor signal quality could not be determined.The circuitry of the sensor is designed to provide a fixed current to the led¿s so no over temperature is possible.A review of the device history record for this lot number found there were no non-conformances in the manufacture of this lot.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the sensor caused a 0.5cm x 0.5 cm burn on the frontal area of a premature patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: INVOS
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): MITG -GALWAY; new mervue industrial park; galway
• MDR Report Key: 7504419
• Report Number: 8020893-2018-00217
• Device Sequence Number: 1775199
• Product Code: MUD
• UDI-Device Identifier: 20884521106229
• UDI-Public: 20884521106229
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K091224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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
• Operator of Device: Health Professional
• Device Model Number: CNN/SNN
• Device Catalogue Number: CNN/SNN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 04/30/2018; 08/08/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 07/19/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 2 DA
• Patient Weight: 1