MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-05-29 for ORION TIMESCO? TP-5572 manufactured by Smiths Medical Asd, Inc..
[109452415]
Smiths medical no longer has a relationship with the supplier, (b)(4) and is therefore unable to receive a response to the scar submitted.
Patient Sequence No: 1, Text Type: N, H10
[109452416]
It was reported that a clinician was using the laryngoscope to intubate a (b)(6) old patient when the scope handle had "bad contact" with the blade. The facility reported that this occurred two times and that during this time, the patient's oxygen saturation levels declined to 20%. The facility also reported that this issue caused an increase in the patient's total operation time. The clinical consequence for the patient was hypoxia and prolonged hospitalization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-10024 |
| MDR Report Key | 7550600 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-05-29 |
| Date of Report | 2018-05-29 |
| Date of Event | 2015-04-29 |
| Date Mfgr Received | 2015-05-04 |
| Date Added to Maude | 2018-05-29 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL NIJMEGEN |
| Manufacturer Street | BIJSTERHUIZEN 22 - 08 6604 LD WIJCHEN |
| Manufacturer City | NIJMEGEN, |
| Manufacturer Country | NL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORION TIMESCO? |
| Generic Name | LARYNGOSCOPE, NON-RIGID |
| Product Code | CAL |
| Date Received | 2018-05-29 |
| Returned To Mfg | 2015-07-21 |
| Catalog Number | TP-5572 |
| Lot Number | 114601 |
| Device Expiration Date | 2016-11-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-05-29 |