MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-26 for HDPFT HDPFT3000 IHD3000 manufactured by Nspire Health Inc.
[128256483]
The nspire pft machine in room 1 had an electrical smell. It was found that the gem module was malfunctioning. The manufacturer was contacted by email and phone. They had the therapist trouble shoot the machine. Technical support felt it was definitely the gem and that it would need to be replaced. Tech support was sent the serial number. No patient was in the room at the time. Manufacturer response for pft system, hdpft (per site reporter). Device is under service contract. Company came to facility and replaced failed gem module with new module and created service report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8101289 |
| MDR Report Key | 8101289 |
| Date Received | 2018-11-26 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-09-05 |
| Report Date | 2018-10-25 |
| Date Reported to FDA | 2018-10-25 |
| Date Reported to Mfgr | 2018-11-26 |
| Date Added to Maude | 2018-11-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HDPFT |
| Generic Name | SPIROMETER, DIAGNOSTIC |
| Product Code | BZG |
| Date Received | 2018-11-26 |
| Returned To Mfg | 2018-09-28 |
| Model Number | HDPFT3000 |
| Catalog Number | IHD3000 |
| Device Availability | R |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NSPIRE HEALTH INC |
| Manufacturer Address | 1830 LEFTHAND CIRCLE LONGMONT CO 80501 US 80501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-26 |