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 2017-07-31 for MCGRATH? MAC ENHANCED DIRECT LARYNGOSCOPE 340-200-000 manufactured by Aircraft Medical Limited.
[81467892]
This device in this report is product code: ccw, device class: 1 regulation number: (b)(4) (510k exempt).
Patient Sequence No: 1, Text Type: N, H10
[81467893]
Medtronic received a report that during patient use, the device powered on, the led on the tip illuminated and the display then went blank a few seconds after powering on. It was stated that the screen showed 111mins while remaining blank. The staff was able to switch the battery on site and the device worked properly after the replacement of the battery. The customer indicated that the battery change caused a delay in the procedure/intubation. It was not specified the amount of time of the delay in the procedure. There was no reported adverse consequence to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010244187-2017-05000 |
| MDR Report Key | 6754999 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-31 |
| Date of Report | 2017-07-10 |
| Date of Event | 2017-06-13 |
| Date Mfgr Received | 2017-07-10 |
| Date Added to Maude | 2017-07-31 |
| 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 | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | AIRCRAFT MEDICAL LIMITED |
| Manufacturer Street | 7 CROSS WAY |
| Manufacturer City | DALGETY BAY,FI KY119JE |
| Manufacturer Country | GB |
| Manufacturer Postal Code | KY11 9JE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCGRATH? MAC ENHANCED DIRECT LARYNGOSCOPE |
| Generic Name | LARYNGOSCOPE, NON-RIGID |
| Product Code | CAL |
| Date Received | 2017-07-31 |
| Model Number | 340-200-000 |
| Catalog Number | 340-200-000 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIRCRAFT MEDICAL LIMITED |
| Manufacturer Address | 7 CROSS WAY DALGETY BAY,FI KY119JE GB KY11 9JE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-31 |