MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX

Model Number	PATIENT INFORMATION CENTER IX
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	11/17/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported the monitor did not generate an alarm for an oxygen desaturation of 30% and the patient passed away.No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.The device was in use on a patient at the time of the event.
Additional Manufacturer Narrative
This complaint is a supplemental to (1218950-2025-000706) due to incorrect registration number used.Box d: based upon updated information, product name changed from 865351 mx40 2.4 ghz smart hopping (b)(4) to 866389 patient information center ix (b)(4) a philips key account manager recalls while performing device inventory for the hospital on (b)(6) 2025 on tisch 14 west, when a nurse reported a few minutes before his onsite arrival a patient expired at (7:15am) while being monitored on the unit.The nurse recalled the patient desaturated to 30 but no alarm was annunciated.The patient was in tisch 14-30, on bed 1.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.
Additional Manufacturer Narrative
A philips key account manager recalls performing device inventory for the hospital on (b)(6) 2025 on tisch 14 west, when a nurse reported a few minutes before his onsite arrival a patient expired at (7:15am) while being monitored on the unit.The nurse recalled the patient desaturated to 30 but no alarm was annunciated.The patient was in tisch 14-30, on bed (b)(6).A good faith effort (gfe) email went out to the key account manager inquiring about the patient's condition, as well as information about the unit at the time of the event.The gfe response was unable to obtain further information.Logs were sent to an internal product support engineer (pse) for further analysis.Summary of technical complaint investigation: the pse indicated there was nothing on 7:15, but there were incidents on (b)(6) at 07:23:38 and at 07:25:49, red alarms generated for desat, when it was 81 respectively 27.But the alarm was acknowledged.Overall, the desat did alarm until it was acknowledged on the pic.The pic is functioning as expected.On (b)(6) 2025 07:26:20, (b)(6) center, t1430-01 sector: tele weak signal generated at 07:26:13.Pic ix: th14esv1, logged inop.On (b)(6) 2025 07:26:20, (b)(6) center, t1430-01 tele weak signal generated at 07:26:13.Pic ix: th14esv1, logged inop.On (b)(6) 2025 07:25:49, (b)(6) center, t1430-01 sector: no spo2t, batt low generated at 07:25:48.Pic ix: th14esv1, logged inop.On (b)(6) 2025 07:25:49, (b)(6) center, t1430-01 desat 27 < 85 ended.T14e-tel13, red alarm.On (b)(6) 2025 07:25:49.(b)(6) center, t1430-01 sector: desat 27 < 85 ended.Pic ix: th14esv1, red alarm.On (b)(6) 2025 07:25:49, (b)(6) center, t1430-01 no spo2t, batt low generated at 07:25:48.T14e-tel13, logged inop.On (b)(6) 2025 07:25:16, inop sound played.Pic ix: th14esv2, alert sound.On (b)(6) 2025 07:25:10, yellow alarm sound played.Pic ix: th14esv2, alert sound.On (b)(6) 2025 07:23:45, inop sound played.Pic ix: th14esv1, alert sound.On (b)(6) 2025 07:23:45, (b)(6) center, t1430-01 acknowledge, pic ix: th14esv1 acknowledge.On (b)(6) 2025 07:23:44, (b)(6) center, t1430-01 acknowledge, pic ix: th14esv1 acknowledge.On (b)(6) 2025 07:23:44, (b)(6) center, t1430-01 acknowledge, pic ix: th14esv1 acknowledge.On (b)(6) 2025 07:23:38, red alarm sound played.Pic ix: th14esv1, alert sound.On (b)(6) 2025 07:23:38, (b)(6) center, t1430-01 sector: desat 81 < 85 generated at 07:23:34.Pic ix: th14esv1, red alarm.On (b)(6) 2025 07:23:38, (b)(6) center, t1430-01 spo2t, 81 <88 ended.T14e-tel13 yellow alarm.On (b)(6) 2025 07:23:38, (b)(6) center, t1430-01 sector: spo2t, 81 <88 ended.Pic ix: th14esv1 yellow alarm.On (b)(6) 2025 07:23:38, (b)(6) center, t1430-01 desat, 81 < 85 generated at 07:23:34.T14e-tel13 red alarm.On (b)(6) 2025 07:23:14, inop sound played.Pic ix: th14esv2, alert sound.On (b)(6) 2025 07:14:23, (b)(6) center, t1430-01 sector: tele battery low generated at 07:14:21.Pic ix: th14esv1 logged inop.On (b)(6) 2025 07:14:23, (b)(6) center, t1430-01 tele battery low generated at 07:14:21.T14e-tel13 logged inop.On (b)(6) 2025 07:14:21, (b)(6) center, t1430-01 user request: ecg - ecg off, t14e-tel13 measurement on/off.Based on the information available, the customer's alleged malfunction could not be confirmed.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: PATIENT INFORMATION CENTER IX
• 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: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 23983571
• Report Number: 9610816-2026-100022
• Device Sequence Number: 10621263
• Product Code: MHX
• UDI-Device Identifier: 00884838104594
• UDI-Public: (01)00884838104594(10)4.0.1.0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K211900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: PATIENT INFORMATION CENTER IX
• Device Catalogue Number: 866389
• Device Lot Number: 4.0.1.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Sex: Unknown