MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-04-26 for CAREEVENT REL A.0 866435 manufactured by Philips Medical Systems.
[106608497]
A follow up report will be submitted once the investigation is complete. Patient information has been requested. Date of death has been requested and not available at time of report.
Patient Sequence No: 1, Text Type: N, H10
[106608498]
It was reported that the hospital staff at the site was performing an investigation of a patient event where the patient expired between 6:40am -7:40am. The customer wanted to understand if there was a delay in care event sending alerts to the mobil phones. Investigation is needed to understand if any philips product caused or contributed to the patient event.
Patient Sequence No: 1, Text Type: D, B5
[119704743]
The customer had questions regarding phone alerts for an asystole alarm that occurred with the patient. It was questioned whether the mobile phone (careevent) alert was at the same time of the piic ix alert. The customer stated that the customer had looked at the piic ix clinical audit logs and was seeing an asystole alarm at 06:56:01 whereas the careevent phone alert shows being at 07:40. The piic ix clinical audit logs gathered from the piic ix central station show that the asystole alarm from 6:56:01 (bedside alarm) was received at the piic and time stamped at 06:55am. This time difference is attributed to the time stamp difference between the various systems and does not mean that there was any lapse in time. Philips recommends synchronizing the time servers to provide better understanding of the alarms between systems. This alarm was then sent from the piic ix to the careevent mobile alert system. The careevent event transcript gathered from the careevent server shows that on (b)(6) 2018 for 663-2 that there was a three star red. Asystole alarm at 6:56:01 am (announce time received at the piic ix) which was successfully matched to the careevent system's location information. The asystole from 06:56:01 was sent to careevent and careevent was notified at 06:53:15 (careevent time stamp). A review of the careevent alarm event transcripts shows that the phone alerts were being provided per normal operation. The careevent transcripts show that the asystole alert was delivered to the 1st level phone and escalated to the 2nd level phone after 30 seconds without acknowledgement, where the 2nd level alert was delivered to the 2nd level caregiver one second later. The asystole is shown as being "read" at 7:17am. Reminders were also provided to the 1st and 2nd level caregivers every three minutes until 7:59. There is no data to support a malfunction of the careevent system. Information was supplied to the customer via written response.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2018-03696 |
| MDR Report Key | 7464322 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-26 |
| Date of Report | 2018-04-20 |
| Date of Event | 2018-04-19 |
| Date Mfgr Received | 2018-04-20 |
| Device Manufacturer Date | 2016-02-12 |
| Date Added to Maude | 2018-04-26 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2018-04-26 |
| Model Number | 866435 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-04-26 |