MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-10-09 for CORPAK BLD-14660 manufactured by Corpak Medsystems.
[257046]
Over past 4-5 months, about 1 out of every 40-60 adult transport circuits breaks at the exhalation valve. The exhalation valve tubing port breaks off and breaks into one or more pieces, leaving a hole in the top cap of the valve about the size of 2/3 of a dime coin. This has occurred when mild to moderate pressure is applied in checking for secure connections of component parts prior to product use. Customer reports no prior experience of this event in several years use of this product. This event could cause a pt to suffer an untoward outcome of death or serious injury if it caused loss of ventilation to the pt, if this loss was not recognized by the caretaker in a timely fashion and/or if it occurred in a setting in which immediate other manual or mechanical ventilatory support was not available to the clinician and pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419949-2002-00006 |
| MDR Report Key | 423014 |
| Report Source | 05,06 |
| Date Received | 2002-10-09 |
| Date Added to Maude | 2002-10-23 |
| 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 | 0 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEPHANIE WASIELEWSKI |
| Manufacturer Street | 100 CHADDICK DRIVE |
| Manufacturer City | WHEELING IL 60090 |
| Manufacturer Country | US |
| Manufacturer Postal | 60090 |
| Manufacturer Phone | 8475374601 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORPAK |
| Generic Name | TRANSPORT VENTILATOR CIRCUIT |
| Product Code | CBP |
| Date Received | 2002-10-09 |
| Returned To Mfg | 2002-10-02 |
| Model Number | NA |
| Catalog Number | BLD-14660 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 412068 |
| Manufacturer | CORPAK MEDSYSTEMS |
| Manufacturer Address | 100 CHADDICK DR WHEELING IL 60090 US |
| Baseline Brand Name | PULMANEX TRANSPORT CIRCUIT |
| Baseline Generic Name | TRANSPORT CIRCUIT |
| Baseline Model No | NA |
| Baseline Catalog No | BLD-14660 |
| Baseline Device Family | TRANSPORT CIRCUIT |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-10-09 |