MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MICROSTREAM CO2 EXTENSION

Model Number	M3015A
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.(b)(6).
Event or Problem Description
The customer reported that there was a broken notch on the case, and an x2 device fell out of the m3015a.The customer was injured as a result of the device falling out of the clip.The extent of the injury was not available at the time of the report.
Additional Manufacturer Narrative
Philips has confirmed the reported module damage; the clip that holds the x2 module in place had been broken, which caused the device to drop on the patient's head.The cause of the damaged clip is unknown, and philips product support engineering (pse) has not requested the device for return.A replacement module has been sent to the customer and remains at the customer site.No subsequent calls have been logged for this device/issue, and no further investigation is warranted.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: MICROSTREAM CO2 EXTENSION
• Common Device Name: MICROSTREAM CO2 EXTENSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8320037
• Report Number: 9610816-2019-00042
• Device Sequence Number: 2285351
• Product Code: DSI
• UDI-Device Identifier: 00884838021556
• UDI-Public: (01)00884838021556
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K993383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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
• Operator of Device: Health Professional
• Device Model Number: M3015A
• Device Catalogue Number: 862393
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other