MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPACE CC & ANESTHESIA

Model Number	866148
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that for bed 7 ip-003 and ip-015, incorrect volume was infused.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.A philips remote service engineer (rse) spoke to the customer.The rse found there were two pumps that encountered multiple disconnection issues; ip-015 from 20 feb 2023 2350h to 21 feb 2023 0306h(located at channel 4), which was then replaced by ip-003(from channel 2 to channel 4).Aside from the multiple disconnections, the rse also detected a ¿reset of total infused volume¿ six times between 2350h to 0943h (plus the pump replacement at 0306h and the pump re-assignment after fluid label change).The rse informed the nurse to help to monitor the issue, and asked the nurse to try and swap the link bridge currently in use by ip-003 in case the issue happens again for troubleshooting/isolation purposes.If the issue persists after replacing/swapping the link bridge, the rse will proceed to request an link bridge (ec80) replacement.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.(b)(6).
Additional Manufacturer Narrative
This was defined as interoperability occurrence.Per monitoring and as per confirmation with rse onsite with the nurse, the issue was stable by 1100h charting time up to present.The investigation concludes that no further action is required at this time.

• Brand Name: INTELLISPACE CC & ANESTHESIA
• Common Device Name: INTELLISPACE CC & ANESTHESIA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16417756
• Report Number: 1218950-2023-00102
• Device Sequence Number: 20178170
• Product Code: DXJ
• UDI-Device Identifier: 00884838085565
• UDI-Public: 00884838085565
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K100272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 866148
• Device Catalogue Number: 866148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown