MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-23 for OPTICHAMBER DIAMOND 1098214 manufactured by Respironics Respiratory Drug Delivery (uk) Ltd.
[92839671]
The optichamber diamond is available with three mask sizes - small, medium and large. Instructions for use supplied with the device states 'recommended patient population: optichamber diamond with small litetouch mask: 0 to 18 months. Optichamber diamond with medium mask: 1 to 5 years. Optichamber diamond with large litetouch mask: 5 years +. ' as the device is restricted to sale by or on the order of a physician or licensed healthcare professional, it is expected that the patient be assessed for adequate fit prior to use, and appropriate mask selected. Device is not life sustaining/ supporting. No other complaints received relating to recommended sizing issues.
Patient Sequence No: 1, Text Type: N, H10
[92839672]
Patient caregiver reported that the (b)(6) patient was admitted to hospital overnight due to use of an optichamber diamond valved holding chamber device with a small litetouch mask that was too small for the patient, and therefore patient did not get the medication needed. Patient was discharged with a larger mask. Caregiver states her daughter is doing fine now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681154-2017-00020 |
| MDR Report Key | 7057130 |
| Date Received | 2017-11-23 |
| Date of Report | 2017-11-09 |
| Date of Event | 2017-11-08 |
| Date Mfgr Received | 2017-11-09 |
| Date Added to Maude | 2017-11-23 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR ALESSANDRO AGOSTI |
| Manufacturer Street | CHICHESTER BUSINESS PARK CITY TANGMERE |
| Manufacturer City | CHICHESTER, PO202FT |
| Manufacturer Country | UK |
| Manufacturer Postal | PO202FT |
| Manufacturer Phone | 8704231549 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OPTICHAMBER DIAMOND |
| Generic Name | HOLDING CHAMBERS, DIRECT PATIENT INTERFACE |
| Product Code | NVP |
| Date Received | 2017-11-23 |
| Model Number | 1098214 |
| Catalog Number | 1098214 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD |
| Manufacturer Address | CHICHESTER BUSINESS PARK CITY FIELDS WAY, TANGMERE CHICHESTER, PO202FT UK PO202FT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-11-23 |