MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR

Model Number M8007A

Device Problem No Audible Alarm (1019)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/31/2017

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that a neonatal intensive care unit (nicu) patient attached to mp70 monitor desaturated down to 21 % but alarm was not heard by nursing staff on (b)(6) 2017 at 16.00.The device was used for monitoring at the time of the alleged malfunction.The patient desaturated down to 21%.The consultant was called and the patient was reintubated.The reintubation was very quick and uneventful.The patient recovered very quickly.

Manufacturer Narrative

Per customer feedback it is stated that the patient was ventilated per endotracheal tubes (ett) and the ett had become dislodged.The nurse looking after him was busy with another baby.She did not appear to have heard the alarm on the monitor go off.The mother of the patient alerted the nursing staff.The consultant was called and the patient was reintubated.The reintubation was very quick and uneventful.The patient recovered very quickly.The alarm limits on the monitor were checked by one of the senior sisters on duty and the alarms were observed to be barely audible even though the volume was set at 5.All the other monitors in the nursery had alarm volumes set at 5 and the alarms were audible.The alarms on this particular monitor were only audible at a volume of 7.The device was taken out of clinical use and was quarantined by the biomedical engineer.He tested the device and the speaker does not appear to be faulty, there was no replacement necessary.Furthermore, he stated that it may be the case that the alarm was dismissed or not heard by the nurse.The event logs of this timeframe were forwarded to philips product support engineering who stated that in the alarm review window it can be seen, that shortly before the alleged time of the event, the alarms were switched off completely for two minutes (15:57 ¿ 15:59) which indicates that the device was working as specified.The biomedical engineer confirmed that the device is now back in clinical use, as there was no trouble found with the device.The evaluation of the provided log files also supports that there was no trouble found with the device.However, the exact cause of the issue remains unknown.The product remains at the customer site and is back in clinical use.The statement of the biomed and the review of the provided log files support that the device was working as specified.However, a malfunction of the device cannot be ruled out.The exact cause of the issue remains unknown.Possible configuration/setting issues cannot be ruled out as the configuration might have been altered in the meantime before the unit was tested by the biomed.Additionally, the available information from this report does not support that this failure represents a systemic, design, or labeling problem.No further investigation or action is warranted.

• Brand Name: MP70 INTELLIVUE PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: richa shah ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6793705
• MDR Text Key: 82661534
• Report Number: 9610816-2017-00249
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

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
• Device Operator: Health Professional
• Device Model Number: M8007A
• Device Lot Number: .
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 08/15/2017
• Supplement Dates Manufacturer Received: 08/07/2017
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2007
• 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