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 2012-07-11 for PRESSURE MANIFOLD 02 THERAPY BC115-05 manufactured by Fisher & Paykel Healthcare Ltd.
[2682845]
A hospital in (b)(6) reported that the port cap on the bc115 pressure manifold popped off during use in 3 events causing patient desaturation. The hospital has further reported that the patients were supported while hospital staff corrected the problem and no further patient consequence was reported.
Patient Sequence No: 1, Text Type: D, B5
[10022482]
(b)(4). The complaint pressure manifold has not been returned to the manufacturer for evaluation. Our investigation is accordingly based on the information provided by the customer and our knowledge of the product. Without the return of the complaint device we are unable to determine what may have caused the problem observed by the customer. All bc115 pressure manifolds are pressure tested prior to distribution. Any pressure manifold which does not pass the pressure test is discarded. The hospital has further reported that it is possible that the port caps may have become disconnected during the handling process of incorporating nitric oxide or in-line treatments during therapy. It is also possible that the port cap may have become loose post production during transport or storage at the user facility. In addition our user instructions that accompany the bc115 pressure manifold state the following: "ensure that any unused ports have their caps and/or plugs in place before use". "inspect for signs of damage. Do not use if damage is apparent".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611451-2012-00447 |
| MDR Report Key | 2649812 |
| Report Source | 05,06,07 |
| Date Received | 2012-07-11 |
| Date of Report | 2012-06-11 |
| Date Mfgr Received | 2012-06-11 |
| Date Added to Maude | 2012-07-11 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. RAYMOND YAN |
| Manufacturer Street | 15365 BARRANCA PARKWAY |
| Manufacturer City | IRVINE CA 926182216 |
| Manufacturer Country | US |
| Manufacturer Postal | 926182216 |
| Manufacturer Phone | 9494534000 |
| Manufacturer G1 | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE EAST TAMAKI |
| Manufacturer City | AUCKLAND, 2013 |
| Manufacturer Country | NZ |
| Manufacturer Postal Code | 2013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESSURE MANIFOLD 02 THERAPY |
| Generic Name | CBP |
| Product Code | CBP |
| Date Received | 2012-07-11 |
| Model Number | BC115-05 |
| Catalog Number | BC115-05 |
| Lot Number | NP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-07-11 |