MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem Defective Alarm (1014)

Patient Problems Hypoxia (1918); Low Oxygen Saturation (2477)

Event Date 02/20/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that the patient was found turning blue due to low oxygen levels on (b)(6) 2019 at approximately 15:30 (3:30pm) hours.The customer alleged that no spo2 alarming had occurred.

Manufacturer Narrative

Complaint evaluation: the device was not returned for evaluation.The field service engineer (fse) assessed the situation remotely on (b)(6) 2019.Under the direction of the fse, the ces performed a clinical audit trail and noted no inops for spo2 which are not logged.The fse also had the ces check to see if a silence occurred or if there was a logging of measurement being turned off and there were none identified.The ces checked the event review and no technical items were noted for spo2 off.The fse remoted into the customer's system and performed a clinical audit, seeing the same data as the ces, and noted an alarm silence at 1427 hours (2:27 pm) with no associated yellow or red alarm performed by (b)(4) which may have been for an inop.Due to two days passing, the fse was not able to further verify at bedside if an inop alarm occurred or if silenced.The clinical audit showed yellow spo2 alarm at 15:27:29 hours (3:27 pm) followed by red spo2 [desat] at 15:27:39 hours (3:27 pm seconds later).Additionally, the nurse said there was no alarm for the probe being off the finger.The fse did a clinical audit remotely and said there was an alarm silenced at about the time the probe was off.The cause of the event remains unknown.The patient continued with monitoring as of (b)(6) 2019 and the device remained at the customer site.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8439326
• MDR Text Key: 139421140
• Report Number: 1218950-2019-02183
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: (01)00884838082236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2019
• 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): Life Threatening