MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-07-19 for N/A OM-2001S manufactured by Ascent Healthcare Solutions.
[1563130]
It was reported that during the procedure the cardiac stabilization device lost suction and the heart slipped off. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[1625373]
.
Patient Sequence No: 1, Text Type: D, B5
[8561261]
The complaint device was evaluated and it was found that when the device knob was tightened, the base was loose. The suction capabilities were not examined since this model does not possess suction capabilities. A review of the device history record for the reported device indicated that the stabilizer passed all applicable tests and inspections prior to release, including a mechanical test on the arm to determine displacement when force is applied to the arm. This is the first complaint that ascent has received for the stabilizer not locking in place.
Patient Sequence No: 1, Text Type: N, H10
[8673528]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090040-2010-00004 |
| MDR Report Key | 1761636 |
| Report Source | 05,06,07 |
| Date Received | 2010-07-19 |
| Date of Report | 2010-08-10 |
| Date of Event | 2010-06-18 |
| Date Mfgr Received | 2010-06-21 |
| Device Manufacturer Date | 2010-01-13 |
| Date Added to Maude | 2010-08-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. MOIRA BARTON-VARTY |
| Manufacturer Street | 10232 SOUTH 51ST STREET |
| Manufacturer City | PHOENIX AZ 85044 |
| Manufacturer Country | US |
| Manufacturer Postal | 85044 |
| Manufacturer Phone | 4807635300 |
| Manufacturer G1 | ASCENT HALTHCARE SOLUTIONS |
| Manufacturer Street | 5307 GREAT OAK DRIVE |
| Manufacturer City | LAKELAND 33815 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33815 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | NQG |
| Product Code | NQG |
| Date Received | 2010-07-19 |
| Returned To Mfg | 2010-07-02 |
| Model Number | OM-2001S |
| Catalog Number | OM-2001S |
| Device Expiration Date | 2011-01-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENT HEALTHCARE SOLUTIONS |
| Manufacturer Address | 10232 SOUTH 51ST STREET PHOENIX AZ 85044 US 85044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-19 |