MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-05-20 for HUDSON OSMO 800-00 manufactured by Teleflex Medical.
[17143177]
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 Sequence No: 1, Text Type: D, B5
[17234739]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2010-00068 |
| MDR Report Key | 1702165 |
| Report Source | 05,06,07 |
| Date Received | 2010-05-20 |
| Date of Report | 2010-04-27 |
| Date Mfgr Received | 2010-04-27 |
| Date Added to Maude | 2010-09-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGELA BROWN, MGR |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | AVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON OSMO |
| Generic Name | OSMO WATER TRAP |
| Product Code | BYH |
| Date Received | 2010-05-20 |
| Model Number | NA |
| Catalog Number | 800-00 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-20 |