MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS; SPO2 8-PIN D-SUB ADAPTER CABLE

Model Number M1943AL

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2019

Event Type  malfunction  

Manufacturer Narrative

Serial number is unknown.A follow-up report will be submitted once the investigation is complete.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Event Description

Customer reported the pulse oximetry not providing a value or waveform during pt code.Neither patient data, nor the date of the occurrence is currently available.

• Brand Name: NA
• Type of Device: SPO2 8-PIN D-SUB ADAPTER CABLE
• 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: 8860844
• MDR Text Key: 153548925
• Report Number: 1218950-2019-05777
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00884838011946
• UDI-Public: (01)00884838011946
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1943AL
• Device Catalogue Number: 989803128651
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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