MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-07-12 for PRECISION MEDICAL OXYGEN BLENDER PM5300 manufactured by Precision Medical Inc..
[113788663]
Fire incident which occurred to an oxygen blender (5300) in a neonatal intensive care unit. This incident was reported by the hospital personnel to the (b)(6) and a complaint sent to us on (b)(6) 2018. Date of actual occurrence is unknown
Patient Sequence No: 1, Text Type: D, B5
[124003104]
[(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[124003105]
Fire incident which occurred to an oxygen blender (5300) in a neonatal intensive care unit. This incident was reported by the hospital personnel to the (b)(6) ministry of health and a complaint sent to us on (b)(6) 2018. Date of actual occurrence is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523148-2018-00002 |
| MDR Report Key | 7682122 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-07-12 |
| Date of Report | 2018-07-13 |
| Date of Event | 2018-07-05 |
| Date Mfgr Received | 2018-07-05 |
| Device Manufacturer Date | 2017-10-12 |
| Date Added to Maude | 2018-07-12 |
| 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 | MRS. KATHY STACKHOUSE |
| Manufacturer Street | 300 HELD DRIVE |
| Manufacturer City | NORTHAMPTON PA 18067 |
| Manufacturer Country | US |
| Manufacturer Postal | 18067 |
| Manufacturer Phone | 6102626090 |
| Manufacturer G1 | PRECISION MEDICAL INC. |
| Manufacturer Street | 300 HELD DR. |
| Manufacturer City | NORTHAMPTON PA 18067 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 18067 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISION MEDICAL OXYGEN BLENDER |
| Generic Name | BLENDER |
| Product Code | BZR |
| Date Received | 2018-07-12 |
| Model Number | PM5300 |
| Catalog Number | PM5300 |
| Lot Number | 101217 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL INC. |
| Manufacturer Address | 300 HELD DRIVE NORTHAMPTON PA 18067 US 18067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-12 |