MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SPO2 SENSOR INFANT FINGER REUSABLE TRANSDUCER; SPO2 INFANT SENSOR

Model Number M1195A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Discoloration (2074)

Event Type  malfunction  

Manufacturer Narrative

Serial number unknown.A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported a sensor caused a patient's finger to be red.

Event Description

The customer reported a sensor caused a patient's finger to be red after an hour of use.There was no medical intervention required.

Manufacturer Narrative

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.An evaluation could not be completed due to the material in question was not going to be returned.

• Brand Name: SPO2 SENSOR INFANT FINGER REUSABLE TRANSDUCER
• Type of Device: SPO2 INFANT SENSOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8794629
• MDR Text Key: 151319933
• Report Number: 9610816-2019-00186
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838010291
• UDI-Public: (01)00884838010291
• Combination Product (y/n): N
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

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 Operator: Other
• Device Model Number: M1195A
• Device Catalogue Number: 989803103261
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1