MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-07-12 for FLOW SELECTOR PM 1000 manufactured by Precision Medical, Inc..
[17029092]
Pt with diagnosis of end stage pulmonary fibrosis was placed on bi-pap machine per doctor's order on event date at 2330. Bi-pap had been used off & on for 9 consecutive days during hospitalization. At 0410 the next day it was found that the oxygen was not piped into the bi-pap machine. The flow selector was set on cannula instead of bi-pap. Pt was cyanotic, unresponsive @ 0410. Oxygen was directed through the bi-pap @ 0410 through the appropriate setting on flow selector. Physician notified. Pt expired @ 0605.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 342493 |
| MDR Report Key | 342493 |
| Date Received | 2001-07-12 |
| Date of Report | 2001-07-10 |
| Date of Event | 2001-06-30 |
| Date Facility Aware | 2001-07-01 |
| Report Date | 2001-07-10 |
| Date Reported to Mfgr | 2001-07-10 |
| Date Added to Maude | 2001-07-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOW SELECTOR |
| Generic Name | OXYGEN OUTLET FLOW SELECTOR |
| Product Code | BXY |
| Date Received | 2001-07-12 |
| Returned To Mfg | 2001-07-11 |
| Model Number | PM 1000 |
| Catalog Number | PM 1000 |
| Lot Number | 0401 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 331831 |
| Manufacturer | PRECISION MEDICAL, INC. |
| Manufacturer Address | 300 HELD DR. NORTH HAMPTON PA 18067 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention | 2001-07-12 |