MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-26 for * 1065 manufactured by King Systems.
[3106593]
While preparing patient in or for procedure it was noted the inflatable face mask was leaking. Mask removed and replaced with no further issues. Replacement mask was same make/model. Upon further inspection after procedure it was noted original mask has large "unsealed" section in seam. Our facility has previously reported this same issue with this mask. No injury to patient, just delay in switching out devices and ensuring new one worked properly. ======================manufacturer response for inflatable face mask, size large, king systems (per site reporter). ======================previously reported this same issue with another mask.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2906001 |
| MDR Report Key | 2906001 |
| Date Received | 2012-11-26 |
| Date of Report | 2012-11-26 |
| Date of Event | 2012-11-24 |
| Report Date | 2012-11-26 |
| Date Reported to FDA | 2012-11-26 |
| Date Added to Maude | 2013-01-10 |
| 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 | 3 |
| 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 | * |
| Generic Name | MASK, GAS, ANESTHETIC |
| Product Code | BSJ |
| Date Received | 2012-11-26 |
| Model Number | * |
| Catalog Number | 1065 |
| Lot Number | UNK |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KING SYSTEMS |
| Manufacturer Address | 15011 HERRIMAN BLVD NOBLESVILLE IN 46060 US 46060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-26 |