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

Model Number M1943AL

Device Problem High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

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

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 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)
• Type of Device: 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
• MDR Text Key: 300766687
• Report Number: 9610816-2022-00427
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00884838011946
• UDI-Public: 00884838011946
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K032979
• 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

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
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: No
• 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