MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-20 for ULTIPOR 100 BB100AF manufactured by Pall Life Sciences.
[992843]
Pt was found to be apneic and unresponsive. Pt was manually bagged to increase o2 sats. Vent alarms indicated that the pt was not receiving adequate volumes. Rt changed out the hme filter and pt returned to full vent support. No adverse effect to the pt. The vent filter was preventing the pt from receiving adequate volumes. The filter was not clogged, it appeared clean. A new filter was attached to the vent and problem resolved. The used filter was saved, mfr contacted and filter sent back to mfr for investigation. The hospital has since discontinued use of this mfr's product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009063 |
| MDR Report Key | 1245773 |
| Date Received | 2008-11-20 |
| Date of Report | 2008-11-20 |
| Date of Event | 2008-10-20 |
| Date Added to Maude | 2008-12-31 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTIPOR 100 |
| Generic Name | HME BREATHING FILTER |
| Product Code | CAH |
| Date Received | 2008-11-20 |
| Returned To Mfg | 2008-10-20 |
| Catalog Number | BB100AF |
| ID Number | 733007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1302738 |
| Manufacturer | PALL LIFE SCIENCES |
| Manufacturer Address | EAST HILLS NY US |
| Brand Name | ULTIPOR 100 |
| Generic Name | HME BREATHING FILTER |
| Product Code | HME |
| Date Received | 2008-11-20 |
| Returned To Mfg | 2008-10-20 |
| ID Number | 733202 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 2 |
| Device Event Key | 1302739 |
| Manufacturer | PALL LIFE SCIENCES |
| Manufacturer Address | EAST HILLS NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-20 |