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

Model Number M3015A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problem Unspecified Heart Problem (4454)

Event Date 09/13/2022

Event Type  Injury  

Event Description

The customer reported that on (b)(6) 2022 at around 2 pm, there was a co2 equipment malfunction.A patient had a heart episode while connected to the device.The m3015a device was swapped out and sent for bench repair.Bench repair determined that the unit contains non-serviceable parts and the entire unit will require exchange.

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Manufacturer Narrative

The catalog number, device name, fda product code and 510k have been corrected in this report.

Event Description

The customer reported that on (b)(6) 2022 at around 2 pm, there was a co2 equipment malfunction.A patient had a heart episode while connected to the device.The m3015a device was swapped out and sent for bench repair.Bench repair determined that the unit contained non-serviceable parts and the entire unit required exchange.A good faith effort (gfe) was made to determine whether the device caused or contributed to the patient heart episode.However, no further information was provided by the customer.The device had a confirmed malfunction.The investigation was unable to determine any relationship of the device malfunction to the reported event.

• 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: 15751134
• MDR Text Key: 303226947
• Report Number: 9610816-2022-00559
• 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,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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2015
• 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
• Patient Sex: Male