MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-30 for ANESTHESIA CIRCUIT - LF manufactured by Medline Industrial Inc..
[41632834]
Reported to risk that a pt was successfully intubated and the anesthesiologist noticed that the bellows on the anesthesia machine was beginning to lose volume. Was not able to deliver an adequate tidal volume to the pt. The anesthesia machine was checked and could not find a problem so the pt was reintubated but it did not take care of the issue. It was decided to change out the entire anesthesia hose circuit. After that was done anesthesia was able to get the tidal volume back to an adequate level and continued to watch the oxygen saturate and tidal volume until satisfied the issue was resolved. Surgery was performed, completed and the pt was discharged home the same day of surgery. Upon inspection of the anesthesia hoses it was determined there were holes in the tubing. Reorder number is dynjaa10435. Risk has been in contact with representative (b)(4) and received a call from medline quality department (b)(4). The product is to be picked up by (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5535745 |
| MDR Report Key | 5535745 |
| Date Received | 2016-03-30 |
| Date of Report | 2016-03-16 |
| Date of Event | 2016-03-07 |
| Date Facility Aware | 2016-03-07 |
| Report Date | 2016-03-16 |
| Date Reported to FDA | 2016-03-16 |
| Date Reported to Mfgr | 2016-03-16 |
| Date Added to Maude | 2016-03-30 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ANESTHESIA CIRCUIT - LF |
| Generic Name | ANESTHESIS CIRCUIT |
| Product Code | OFP |
| Date Received | 2016-03-30 |
| Lot Number | 16AB1606 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIAL INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-30 |