MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE; INTELLIVUE MICROSTREAM EXTENSION

Model Number	867041
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that an x3 module fell from the co2 microstream extension module.The x3 struck the top of the pregnant nurse's belly.The nurse required several hours of monitoring in the hospital's labor and delivery unit.No additional information concerning the injury to the nurse or her fetus is available.No delay in patient treatment has been reported.
Additional Manufacturer Narrative
A philips field service engineer (fse) visited the customer site, confirmed the reported issue and gathered information surrounding the event.The fse determined a replacement module housing top was needed to resolve the issue.The philips field service engineer (fse) confirmed a product malfunction; the x3 fell due to a faulty latch on the extension module's housing.The fse has supplied a replacement top housing (453564685391, mx_ext housing top), which contains the latch, as a solution to this incident.Philips is investigating this issue through an internal corrective and preventive action, therefore no product return has been performed.No further investigation is required.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: INTELLIVUE
• Common Device Name: INTELLIVUE MICROSTREAM EXTENSION
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9082527
• Report Number: 9610816-2019-00244
• Device Sequence Number: 2589579
• Product Code: MHX
• UDI-Device Identifier: 00884838083585
• UDI-Public: (01)00884838083585
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K172904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019

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: 867041
• Device Catalogue Number: 867041
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1