MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SPO2 SENSOR ADULT/PEDIATRIC EAR CLIP REUSABLE TRANSDUCER; SPO2/PLETH SENSOR

Model Number M1194A

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Manufacturer Narrative

Cannot confirm serial number.A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer stated that the sp02 measurement is not correct.There was no reported patient impact.

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.

• Brand Name: SPO2 SENSOR ADULT/PEDIATRIC EAR CLIP REUSABLE TRANSDUCER
• Type of Device: SPO2/PLETH SENSOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 7869342
• MDR Text Key: 120252051
• Report Number: 9610816-2018-00224
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1194A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1