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 2020-03-30 for PIIC IX HARDWARE 866424 manufactured by Philips Medical Systems.
[185520893]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[185520894]
The customer reported the spo2 parameter disappears in a sector when the sector is minimized. A patient expired on approximately (b)(6) 2020. The customer is asking for help in determining if the patient was tampering with the telemetry device or if the patient had removed the device leading up to a code event. They need to understand and if there was a delay in response, absent inop alarm, etc. That contributed to death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2020-01994 |
| MDR Report Key | 9897831 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2015-09-15 |
| Date Added to Maude | 2020-03-30 |
| 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 | PIIC IX HARDWARE |
| Generic Name | CENTRAL STATION MONITOR |
| Product Code | MHX |
| Date Received | 2020-03-30 |
| Model Number | 866424 |
| 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. Death | 2020-03-30 |