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.
[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
| Report Number | 1218950-2018-02697 |
| MDR Report Key | 7358388 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-21 |
| Date of Report | 2018-02-21 |
| Date of Event | 2018-02-17 |
| Date Mfgr Received | 2018-02-21 |
| Device Manufacturer Date | 2017-02-14 |
| Date Added to Maude | 2018-03-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BETTY HARRIS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREEVENT REL A.0 |
| Generic Name | CARDIAC MONITOR |
| Product Code | MSX |
| Date Received | 2018-03-21 |
| Model Number | 866435 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-03-21 |