MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SP02 9-PIN D-SUB ADAPTER CBL 3.0M(8-PIN)

Model Number	M1943AL
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there is a difference between the spo2 and tcpo2 readings.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
Philips reached out for more information regarding the incident and to see if the product was available for return.We were informed by the customer that the device was not available for evaluation.Without the material being returned, we are not able to perform an evaluation to determine the cause of the reported incident.A philips application specialist went onsite to the customer and provided product support on how the cable should measure.The customer was provided original philips accessories to resolve this issue.H3 other text : device not returned.
Event or Problem Description
The customer reported high readings with the spo2 adapter cable.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

• Brand Name: SP02 9-PIN D-SUB ADAPTER CBL 3.0M(8-PIN)
• Common Device Name: SP02 9-PIN D-SUB ADAPTER CBL 3.0M(8-PIN)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15223693
• Report Number: 9610816-2022-00427
• Device Sequence Number: 14928153
• Product Code: DQA
• UDI-Device Identifier: 00884838011946
• UDI-Public: 00884838011946
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Device Model Number: M1943AL
• Device Catalogue Number: M1943AL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown