MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-19 for REUSABLE FLEXIBLE TUBING 622038 manufactured by Respironics Inc..
[139310980]
The manufacturer received information alleging ventilator circuit tubing "crushed in on itself. " at this time, it is not known if intervention was required. The manufacturer is currently investigating this event and a follow-up report will be filed when the investigation is complete.
Patient Sequence No: 1, Text Type: D, B5
[143686506]
It was initially reported, the manufacturer received information alleging ventilator circuit tubing "crushed in on itself. " the tubing was returned to the manufacturer for evaluation. No deformities or material abnormalities were observed. The manufacturer concludes the tubing is within design specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2019-00623 |
| MDR Report Key | 8433523 |
| Date Received | 2019-03-19 |
| Date of Report | 2019-04-02 |
| Date of Event | 2019-03-11 |
| Date Mfgr Received | 2019-04-02 |
| Date Added to Maude | 2019-03-19 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ADAM PRICE |
| Manufacturer Street | 312 ALVIN DRIVE |
| Manufacturer City | NEW KENSINGTON PA 15668 |
| Manufacturer Country | US |
| Manufacturer Postal | 15668 |
| Manufacturer G1 | RESPIRONICS INC. |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE PA 15668 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15668 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | REUSABLE FLEXIBLE TUBING |
| Generic Name | ACCESSORY TO CONTINUOUS VENTILATOR (RESPIRATOR) |
| Product Code | MOD |
| Date Received | 2019-03-19 |
| Model Number | 622038 |
| Catalog Number | 622038 |
| Lot Number | 120418 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS INC. |
| Manufacturer Address | 1001 MURRY RIDGE LANE MURRYSVILLE PA 15668 US 15668 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-19 |