MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS

Model Number	M1196A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unable to confirm serial number.
Event or Problem Description
It was reported to philips that the device does not read the saturation properly, incorrect values.There was no patient involvement.

• Brand Name: NA
• Common Device Name: NA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10697065
• Report Number: 1218950-2020-06182
• Device Sequence Number: 19667116
• Product Code: DQA
• UDI-Device Identifier: 00884838001381
• UDI-Public: (01)00884838001381
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K062605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M1196A
• Device Catalogue Number: 989803128631
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1