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 2013-08-23 for PEDIATRIC BREATHING CIRCUIT 1552016 manufactured by Vital Signs Colorado, Inc..
[62339982]
Product lot number has not been confirmed, therefore, device manufacture date is unk. The customer reported that lot # 6270a was in inventory, but it is unk if that is the lot involved in the reported event. Ge healthcare's investigation is ongoing. A f/u report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[62339983]
The customer reported a blue cap occluded the inspiratory end of the pediatric breathing circuit at the cuff, preventing oxygen and anesthesia flow to the pt. During inhalation, induction on a pediatric pt undergoing adenoidectomy, tonsillectomy, and bilateral myringotomy procedure, the pt's sao2 level dropped to the 70's. The pt was not falling asleep and surgery had not yet started. The pt was switched to an ambu bag, ventilation was initiated, and the inspiratory circuit was removed. The circuit was checked and it was reported that, "the cap was on the end of the circuit where it plugged into the anesthesia machine; fitting inside the port on the anesthesia machine. " the cap was removed and the case resumed. It was reported that the event was approx 10 - 15 seconds in duration, the pt was not given any medication as a result of the event, there was no pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718887-2013-00004 |
| MDR Report Key | 3345865 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2013-08-23 |
| Date of Report | 2013-07-26 |
| Date of Event | 2013-07-24 |
| Date Mfgr Received | 2013-07-26 |
| Date Added to Maude | 2013-09-12 |
| 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 | JOY SONSALLA |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | VITAL SIGNS COLORADO, INC. |
| Manufacturer City | ENGLEWOOD CO |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PEDIATRIC BREATHING CIRCUIT |
| Generic Name | CIRCUIT, BREATHING |
| Product Code | OFP |
| Date Received | 2013-08-23 |
| Model Number | 1552016 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VITAL SIGNS COLORADO, INC. |
| Manufacturer Address | ENGLEWOOD CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-23 |