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 2020-03-24 for MX40 1.4 GHZ SMART HOPPING 865350 manufactured by Philips Medical Systems.
[184641140]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[184641141]
The customer reported that the mx40/picix system did not alarm on (b)(6) 2020 at 0700 6n telemetry. The customer stated that there was a flatline patient event and they did not hear any alarms. At this time there is no additional information.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1218950-2020-01879 |
MDR Report Key | 9871054 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2020-03-24 |
Date of Report | 2020-03-06 |
Date of Event | 2020-03-03 |
Date Mfgr Received | 2020-03-06 |
Device Manufacturer Date | 2019-05-09 |
Date Added to Maude | 2020-03-24 |
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 | MX40 1.4 GHZ SMART HOPPING |
Generic Name | MX40 1.4 GHZ SMART HOPPING |
Product Code | DSI |
Date Received | 2020-03-24 |
Model Number | 865350 |
Catalog Number | 865350 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | N |
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 | 2020-03-24 |