CAREEVENT REL A.0 866435

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-03-21 for CAREEVENT REL A.0 866435 manufactured by Philips Medical Systems.

Event Text Entries

[103073006] A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


[103073007] It was reported that a philips brady alert from bed 562 on (b)(6) 2018 at 18:06 (6:06 pm) was not sent to the careevent end device. The nurse did not receive the page in question and the patient became bradycardic, hypotensive & stopped breathing and required emergent care. The patient required resuscitation and subsequently survived. It is considered a serious injury if the patient requires emergent care. Per the customer, on saturday the patient in room (b)(6), who was a post op day 1 cabg (coronary artery bypass graft) was doing well: extubated in the am, iabp (intra-aortic balloon pump) out in the afternoon, stable vital signs. The caregiver went to hang an iv down the hall in their other patient? S room, and the patient became bradycardic, hypotensive and stopped breathing. The piic red alarm went off, but the caregiver's paging phone didn? T, although they had logged into the paging system at least twice during the day. Nurse saw it on the monitor on b wing and ran over, and nurse eventually was able to get there as well, being busy next door. They were buddied, and nurse said her phone didn? T alarm either.
Patient Sequence No: 1, Text Type: D, B5


[108858851] It was reported that a philips brady alert from bed 562 on (b)(6) 18 at 18:06 (6:06 pm) was not sent to the careevent end device. The nurse and nurse buddy did not receive the page in question and the patient became bradycardic, hypotensive & stopped breathing and required emergent care. The patient required resuscitation and subsequently survived. Per product support engineer, in response to the "patient involvement" event that occurred at (b)(6) medical center on (b)(6) 18 @ 1806, philips conducted an investigation of the philips software, and concluded that the system functioned as designed. The investigation found that one philips alert message was delivered from philips piicix bed "562 smf" to careevent on (b)(6) 18 @ 18:06. This alert message a red spo2 text="desat 82 < 85" was assigned to level 1 careevent assignment nurse=(b)(6) and to level 2 careevent assignment buddy nurse= (b)(6) with level 3 ce assignment escalation set up. Both assigned caregivers had no end devices logged in at the time of the issue so the alert was not delivered to an end device due to this reason. The careevent system is considered as a factor in the adverse event although the careevent system was working as designed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1218950-2018-02697
MDR Report Key7358388
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-03-21
Date of Report2018-02-21
Date of Event2018-02-17
Date Mfgr Received2018-02-21
Device Manufacturer Date2017-02-14
Date Added to Maude2018-03-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. BETTY HARRIS
Manufacturer Street3000 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9786871501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCAREEVENT REL A.0
Generic NameCARDIAC MONITOR
Product CodeMSX
Date Received2018-03-21
Model Number866435
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2018-03-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.