MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-13 for MODEL 91369, SL2400 COMPACT MONITOR 91396 * manufactured by Spacelabs Medical Inc..
[788675]
Infant pt was resting in a bassinet, under an infant warmer with oxygen hood in place. Oxygen hood was placed over the infant's head and was attached to an oxygen air bladder for administration of 100% oxygen. As staff approached the bassinet, they observed a flash of flames under the oxygen hood. Staff removed hood and removed oxygen from the wall. Staff used a blanket to extinguish fire.
Patient Sequence No: 1, Text Type: D, B5
[8093431]
This issue is the subject of a medwatch that has been reported to the fda by the hosp. This report is intended to serve as spacelabs healthcare's initial medical device report on this matter. A few key facts should be noted. Due to the uniqueness of the reported event, the hosp has contracted with outside investigators to perform a complete investigation into the event. Hosp has filed their mdr and included the manufacturers of all equipment that was present in the pt's environment, but has not made any statement of failure or malfunction associated with any prod. The investigating team is creating an investigation protocol at this time to govern their investigation, but has not [at this time] started an investigation. We have contacted the hosp's risk mgmt via email and letter dated february 12, 2008 with an acknowledgement letter requesting participation in the eval of spacelabs healthcare equipment. We have no firm indication [at this time] when we will be able to evaluate the spacelabs equipment as we are not controlling the investigation. We intend to make every effort to assist in the investigation as it relates to spacelabs prods. We have reviewed our complaint files and have not rec'd any other reports of events similar to this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3023361-2008-00001 |
| MDR Report Key | 999776 |
| Report Source | 05 |
| Date Received | 2008-02-13 |
| Date of Report | 2008-01-30 |
| Date of Event | 2008-01-22 |
| Date Mfgr Received | 2008-01-31 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2008-02-21 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | GARY PARKER, MGR |
| Manufacturer Street | 5150 220TH AVE SE |
| Manufacturer City | ISSAQUAH WA 98029 |
| Manufacturer Country | US |
| Manufacturer Postal | 98029 |
| Manufacturer Phone | 4256577200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MODEL 91369, SL2400 COMPACT MONITOR |
| Generic Name | SL2400 COMPACT MONITOR |
| Product Code | FOG |
| Date Received | 2008-02-13 |
| Model Number | 91396 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 968358 |
| Manufacturer | SPACELABS MEDICAL INC. |
| Manufacturer Address | P.O. BOX 7018 ISSAQUAH WA 98027 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2008-02-13 |