MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH MICROSTREAM CO2 EXTENSION

Model Number M3015A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 06/16/2022

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported, the user was reaching for cords to obtain vital signs, when the co2 monitor fell and landed on the patient¿s head.The user identified 2 of the 4 safety clips that lock the module into place were found to be broken.

Event Description

It was reported, the user was reaching for cords to obtain vital signs, when the co2 monitor fell and landed on the patient¿s head.The user identified 2 of the 4 safety clips that lock the module into place were found to be broken.There have been several attempts for additional information made with no information provided.The cause of the event was reported to be the broken safety clips, but that was not confirmed by a philips technician.The cause of the event is unknown.It is unknown if the issue was resolved.The status of patient is unknown.The device remained on site.

Manufacturer Narrative

H3 other text : good faith effort with no response from customer.

• Brand Name: MICROSTREAM CO2 EXTENSION
• Type of Device: MICROSTREAM CO2 EXTENSION
• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14999395
• MDR Text Key: 295771133
• Report Number: 9610816-2022-00373
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838021556
• UDI-Public: 00884838021556
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: M3015A
• Device Catalogue Number: M3015A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2011
• 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
• Patient Age: 7 YR
• Patient Sex: Male
• Patient Weight: 21 KG