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

Model Number M3015A

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 10/26/2021

Event Type  Injury  

Manufacturer Narrative

A philips response service engineer (rse) spoke to the customer.The customer was advised to perform a electrical safety check.The customer called back and mentioned that a inspection of the complete unit was performed, and no trouble was found.Further relevant information was requested (like if the nurse needed to be treated), but no response was received.The exact cause for the reported issue remains unknown.Although the reported issue could not be confirmed during testing, a malfunction of the device cannot be ruled out.The product remains at the customer site.

Event Description

It was reported that when plugging in a microstream co2 extension module into a intellivue mp30 the nurse got shocked.The device was in use on a patient at the time of the reported issue.Further details about the nurse, such as gender, age, height and weight had not been made available.The nurse got shocked.

• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12848271
• MDR Text Key: 281395423
• Report Number: 9610816-2021-10502
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/15/2008
• 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): Hospitalization