MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX800 PATIENT MONITOR

Model Number 865240

Device Problems Loose or Intermittent Connection (1371); Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problems Low Oxygen Saturation (2477); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2022

Event Type  Injury  

Event Description

The customer reported that the spo2 sensor has become slight loose or fallen off or unable to get accurate reading.This causes an inop alarm for the disconnect however can sometimes not be heard in a busy icu.A neonatal unit where spo2 is their main concern- they would like the ability for this to be a red to be able to ensure sp02 disconnects are looked at immediately.The inop alarms may be missed due to the nature of the tone.This can cause clinical risk if the inop alarm is missed and a baby has a respiratory event whilst not monitoring sp02 or searching for spo2 pleth.A red alarm would help alert staff when sp02 readings are lost.The baby was being monitored with massimo spo2 whilst in fathers arms.Spo2 sensor may have been loose and therefore went to ? for sp02 reading- giving an inop alarm.Babies hr and rr were within normal limits during the time therefore did not alarm.Father alerted staff of the ? on the monitor (has lost reading for approximately 10mins when nurse check on central station).The staff would like the ability to have spo2 inop such a spo2 disconnect as a red alarm or sp02 ? as a red alarm to help bring immediately attention to this issue which is important to all neonatal issues.The device was reported to be in use on a patient.It was reported that the baby was unresponsive and needed resuscitation.

Manufacturer Narrative

A follow-up report will be submitted when additional information is received or upon completion of the investigation.

Event Description

The customer reported a baby was being monitored with massimo spo2 whilst in father¿s arms.An spo2 sensor may have been loose, fell off, or was unable to get an accurate reading.Therefore, an inop was generated for spo2.The babies heart rate (hr) and respiratory rate (rr) were within normal limits during the time and therefore did not alarm.The father alerted the staff of the inop on the monitor.The spo2 reading was lost for approximately ten minutes when the nurse checked on central station.The baby was unresponsive and needed resuscitation.

Manufacturer Narrative

(b)(6) 2022 (jmh): b2, b5, h6.

Manufacturer Narrative

H10: corrected the coding in patient outcome code grid and health impact grid.

Event Description

The customer reported a baby was being monitored with massimo spo2 whilst in father¿s arms.An spo2 sensor may have been loose, fell off, or was unable to get an accurate reading.Therefore, an inop was generated for spo2.The babies heart rate (hr) and respiratory rate (rr) were within normal limits during the time and therefore did not alarm.The father alerted the staff of the inop on the monitor.The spo2 reading was lost for approximately ten minutes when the nurse checked on central station.The baby was unresponsive and needed resuscitation.Additional information was received that a registered nurse was in the room and the patient was resuscitated successfully.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• Type of Device: INTELLIVUE MX800 PATIENT MONITOR
• 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 ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15677769
• MDR Text Key: 302473376
• Report Number: 9610816-2022-00542
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838020733
• UDI-Public: 00884838020733
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865240
• Device Catalogue Number: 865240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2018
• 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): Required Intervention; Other