MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP70

Model Number 862451

Device Problem Incorrect Measurement (1383)

Patient Problem Insufficient Information (4580)

Event Date 04/24/2022

Event Type  Injury  

Event Description

It was reported: an incident occurred and the customer had questions with regards to the potential of the ecto2 monitoring sample line becoming blocked by fluid and what impact this would have in terms of etco2 monitoring and subsequent alarms.The device was in clinical use and there was an adverse event reported.No further information regarding the reported issue were available at the time of the reporting decision.

Manufacturer Narrative

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

Manufacturer Narrative

A philips product support engineer (pse) was provided, by the customer, with a photograph of the device setup at the customer site.The pse reviewed the information and advised the customer on the device functionality between the philips patient monitor with regards to the co2 measurement.The pse reviewed the information and advised the customer on the device functionality between the philips patient monitor with regards to the co2 measurement.We will consider the customer resolved the issue with the information provided.

Event Description

It was reported: an incident occurred and the customer had questions with regards to the potential of the ecto2 monitoring sample line becoming blocked by fluid and what impact this would have in terms of etco2 monitoring and subsequent alarms.The device was in clinical use and there was an adverse event reported.No further information regarding the reported issue were available at the time of the reporting decision.

• Brand Name: INTELLIVUE MP70
• Type of Device: INTELLIVUE MP70
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: derek sammarco ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 14341633
• MDR Text Key: 291287420
• Report Number: 9610816-2022-00213
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K151681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 862451
• Device Catalogue Number: 862451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 04/24/2022
• Supplement Dates FDA Received: 06/17/2022
• 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
• Patient Outcome(s): Required Intervention