MAUDE Adverse Event Report: PHILIPS NORTH AMERICA, LLC PHILIPS M3015A CO2 MMS MODULE; DETECTOR AND ALARM, ARRHYTHMIA

Model Number PHILIPS M3015A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 06/16/2022

Event Type  malfunction  

Event Description

Patient in emergency department.Philips co2 monitor fell and landed on patient's head when reaching for cords to obtain vital signs.Two of the four safety clips that lock the module into place were found to be broken.

• Brand Name: PHILIPS M3015A CO2 MMS MODULE
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PHILIPS NORTH AMERICA, LLC; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 14884812
• MDR Text Key: 295316641
• Report Number: 14884812
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PHILIPS M3015A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2022
• Device Age: 11 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2555 DA
• Patient Sex: Male
• Patient Weight: 21 KG
• Patient Ethnicity: Hispanic