MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-28 for CAREEVENT REL A.0 866435 manufactured by Philips Medical Systems.
[93050624]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[93050625]
The customer alleged that an alarm was not sent to the care event paging phones which should have occurred (b)(6) 2017 at 09:08. It was reported that the patient required emergent care and subsequently expired.
Patient Sequence No: 1, Text Type: D, B5
[104547968]
The care event paging devices were in normal use for secondary monitoring pages. Paging is labeled as a means of alarm information notification. Issues with paging would not prevent the monitoring device from continuing to provide real-time monitoring and alarms. The philips careevent system is not intended to provide real-time information, nor is it the source of alarms, nor is it a replacement for alarming devices. Therefore this issue would not be likely to cause or contribute to death or serious injury if the paging device is used per product labeling. The delivered event detail by location log shows that for the patient in room (b)(6) there were 19 alarms generated in the timeframe in question (from timestamp 2017 (b)(6) 09:09:08 to 09:26:49) including twelve (12) tachy alarms and two ( 2) asystole alarms. The asystole alarms show timestamp 09:19:42 and 09:20:33. Per the careevent transcript (event transcript) from (b)(6) 2017 ,the alarm for room (b)(6): vfib/vtach alarm was issued (meddelad /? Issued? ) from the careevent server and delivered (levererad) to the end users nurse (ssk) and assistant nurse (usk) at timestamp 2017 (b)(6) 09:10:42 and then read (las) by both nurse and assistant nurse within one second (2017 (b)(6) 09:10:43). It also shows that the careevent server resent the page which was delivered (levererad) to the end users nurse (ssk) and assistant nurse (usk) at timestamp 2017 (b)(6) 09:11:13 and then read (las) by the assistant nurse (usk) at 09:11:14 (after one second) and by the nurse at 09:11:15 (after two seconds). The information shows that the system was working as designed. The device is considered in use at the customer site. No parts were replaced. The customer was sent a formal response as per attachment. No malfunction is supported. The customer claimed that they did not see a paging alarm and that a delay in treating the patient was a factor in the adverse event. Investigation of the issue found that the careevent paging system was working normally and that patient alarms were being annunciated at the central station and were being sent normally to the paging server and then to the appropriate paging devices. If the customer is relying on paging as primary monitoring this would be outside of labeling and normal and expected use. The philips careevent system is not intended to provide real-time information, nor is it the source of alarms, nor is it a replacement for alarming devices. Use of the careevent paging system is considered to have been a factor in the adverse patient event as there was a delay in treatment due to the customer? S use of the pagers although there was no malfunction of the paging system. Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[108296102]
The customer alleged that an alarm was not sent to the careevent mobile phones which should have occurred (b)(6) 2017 for room (b)(6) at approximately 09:08. It was reported that the patient required emergent care and subsequently expired. There was also an allegation that the timestamps showed a delay in receiving the alarms on the caregivers mobile phones. Philips investigation determined that the careevent notification system was working as designed to deliver supplemental medical device data and that careevent users were notified of the alarms generated by the primary alarming source for the involved patient. There are multiple factors that influence the generation of the timestamps during an event. These timestamp differences did not impact the timely delivery of messages to the careevent mobile application; however, it is recommended to synchronize the ntp server(s) for careevent, piic ix and the bedside monitor going forward. Philips provides a comprehensive product portfolio for patient monitoring and use of mobile applications. Although the primary alarm source generates audible and visible alarms, careevent provides caregivers with notifications and visibility to patient alarms on their smartphone. The careevent instructions for use (ifu) provides the following intended use statement:? The intended use of philips careevent is to deliver supplemental medical device data associated with physiological alarms, technical alarms, clinical notifications, nurse call alarms and informational messages to a healthcare professional? S end device. The user may receive visual or audible notifications, and/or other message notification types based on the communicator in use. Philips careevent... Does not generate the alarm, alter the behavior of the alarm-generating system, replace the alarming system that generates the alarms, nor is it intended to provide real-time information, therefore the device producing the alarm or event remains the primary notification system. Philips careevent provides confirmed delivery features when it is used with the philips careevent mobile application on philips-approved android devices. The philips careevent mobile application either communicates alarm information that is sent from the philips careevent server, or the user is notified that communication is not possible. Receipt of alarm messages or events by all other external devices is not confirmed and delivery to the end device is not guaranteed.? (careevent b. 0) ifu, document number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2017-07999 |
| MDR Report Key | 7062870 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-28 |
| Date of Report | 2017-11-23 |
| Date of Event | 2017-11-17 |
| Date Mfgr Received | 2017-11-23 |
| Device Manufacturer Date | 2016-07-13 |
| Date Added to Maude | 2017-11-28 |
| 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 | 2017-11-28 |
| 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. Death | 2017-11-28 |