| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HUDSON OSMO | OSMO WATER TRAP | TELEFLEX MEDICAL | BYH | NA | 800-00 | UNK | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-05-20 | 0 |
Patient 1
THE CUSTOMER REPORTS THE EVENT AS: WHILE USING THE OSMO ON A SERVO 1 VENTILATOR, THE DIFFERENCE BETWEEN THE MEASURED TIDAL VOLUMES AND THE COMPLIANCE WERE TOO LARGE. WITH THE SMALLER TIDAL VOLUMES IN NEONATAL AND PEDIATRIC SETTING, THE SERVO 1 VENTILATOR CAN'T COMPENSATE FOR THE COMPLIANCE DIFFERENCE AS IT ACCUMULATES CONDENSATION. NO PT INJURY REPORTED.
Patient 1
EVAL: DEVICE HISTORY REVIEW. MANUFACTURING PROCEDURE REVIEW. RESULTS: OTHER - THE DEVICE HISTORY REVIEW WAS REVIEWED; NO ISSUES RELATED TO THE REPORTED COMPLAINT DESCRIPTION WERE FOUND. THE DEVICE HISTORY REVIEW INDICATES THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. THE LOT NUMBER IS UNK FOR THIS COMPLAINT, BUT LOT NUMBER 02K0901262 WAS SUBSTITUTED FOR REVIEW. THE MANUFACTURING PROCEDURE FOR CATALOG # 800-00 WAS REVIEWED AND NO FINDINGS THAT CAN POTENTIALLY RELATE TO THE REPORTED ISSUE WERE FOUND. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. THERE WERE NO REPORTED SIMILAR COMPLAINTS FOR OTHER CATALOG CODES IN THIS PRODUCT FAMILY. DUE TO THE LACK OF PRODUCT SAMPLE AND LOT NUMBER, THE MANUFACTURING FACILITY IS UNABLE TO CONDUCT AN INVESTIGATION AND DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. IF THE PRODUCT SAMPLE OR LOT NUMBER BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED AND A FOLLOW UP REPORT WILL BE SUBMITTED.