MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-21 for SQUISHON 3 91033-3 manufactured by Philips Respironics -chmv.
[5212099]
The customer reported they received 10, 91033-3 squishon 3 that some were moldy and some were leaking. There was no reported patient incident/injury.
Patient Sequence No: 1, Text Type: D, B5
[12668148]
(b)(4). A f/u report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2014-07540 |
| MDR Report Key | 4330081 |
| Report Source | 06 |
| Date Received | 2014-08-21 |
| Date of Report | 2014-07-22 |
| Date Mfgr Received | 2014-07-22 |
| Date Added to Maude | 2014-12-19 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANCY ATAIDE |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SQUISHON 3 |
| Generic Name | FMP |
| Product Code | FMP |
| Date Received | 2014-08-21 |
| Model Number | 91033-3 |
| Lot Number | UNK |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS RESPIRONICS -CHMV |
| Manufacturer Address | 191 WYNGATE DR MONROEVILLE PA 15146 US 15146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-21 |