MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-18 for COOLFLOW? IRRIGATION PUMP M-5491-01 CFP001 manufactured by Hei, Inc..
[46628187]
The investigation has begun but it has not been completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[46628188]
It was reported the user cannot increase flow rate while delivering rf energy during ablation procedure. Multiple attempts have been made to obtain clarification to this complaint. However, no further information has been made available. (b)(4) takes conservative approach to report this issue.
Patient Sequence No: 1, Text Type: D, B5
[48165552]
(b)(4). It was reported that client cannot increase flow rate while delivering rf energy. Repair follow up was performed and it was informed that pump will not be sent for testing as it is working correctly. Service was declined. The dhr review verifies that the device was manufactured in accordance with documented specification and procedures. Complaint was unable to confirm.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721752-2016-00005 |
| MDR Report Key | 5664343 |
| Date Received | 2016-05-18 |
| Date of Report | 2016-04-26 |
| Date of Event | 2016-04-26 |
| Date Mfgr Received | 2016-04-26 |
| Date Added to Maude | 2016-05-18 |
| 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 | JOAQUIN KURZ |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893837 |
| Manufacturer G1 | HEI, INC. |
| Manufacturer Street | 4801 NORTH 63RD. ST |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOLFLOW? IRRIGATION PUMP |
| Generic Name | SIMILAR DEVICE CFP002, PMA # P990071/S5 |
| Product Code | KYG |
| Date Received | 2016-05-18 |
| Model Number | M-5491-01 |
| Catalog Number | CFP001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEI, INC. |
| Manufacturer Address | 4801 NORTH 63RD. ST BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-18 |