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 2020-02-05 for CAREEVENT REL A.0 866435 manufactured by Philips Medical Systems.
[177805915]
Philips product support engineer (pse) spoke to the customer careevent manager (cem), and reviewed logs from the careevent. The investigation found that one alarm message ***xbrady 76 < 80 was delivered from bed 589a to clinical team members at 19:49:40. The first level nurse paging device (pivot 8742 smartphone) was not assigned to careevent assignments. At the same time, the buddy nurse received the philips alarm ***xbrady 76 < 80. The cem had tested the bedside monitor and philips information center being used with the paging system, and both were okay and in use. There was no product malfunction; this is considered a user issue, as the staff member's paging device was not assigned to careevent assignments. A philips product support engineer (pse) conducted an investigation of the philips software, and concluded that the system functioned as designed. The device remains in use at the customer site. No subsequent calls have been logged for this device/issue. No further investigation or action is warranted at this time. Patient information requested not available at time of report.
Patient Sequence No: 1, Text Type: N, H10
[177805916]
The customer reported that an alarm was not received on (b)(6) 2020 at 19:49:40 for a patient in room 589a. The output was on aruba access points (ap) with pivot 8742 smart phones. Error "no device assignment" listed in event transcript report. The patient had suffered a cardiac arrest. The staff entered the patient room for routine blood draw and found the patient had arrested with a flat line heart rate and not registering a pulse oxygenation. The patient was able to be resuscitated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2020-00866 |
| MDR Report Key | 9670774 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2016-10-06 |
| Date Added to Maude | 2020-02-05 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-02-05 |
| Model Number | 866435 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-02-05 |