MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-12-10 for PMT HALO VEST 1233-5 manufactured by Pmt Corp.
[1442810]
Customer reported that a pt that was wheelchair bound was wearing a pmt halo, the cardiac crease on the halo cracked. Causing the vest to break at the crease. A new front piece was ordered and placed on the pt. No serious harm or injury occurred to the pt.
Patient Sequence No: 1, Text Type: D, B5
[8347164]
As the pt was wheelchair bound, added stress to the front portion of the vest was inevitable. The health professional should have ordered a custom vest to ensure that the fit of the halo vest was appropriate to the situation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182979-2009-00004 |
| MDR Report Key | 1571644 |
| Report Source | 06 |
| Date Received | 2009-12-10 |
| Date of Report | 2009-12-11 |
| Date Mfgr Received | 2009-10-09 |
| Date Added to Maude | 2010-07-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ERIC CAILLE |
| Manufacturer Street | 1500 PARK RD |
| Manufacturer City | CHANHASSEN MN 55317 |
| Manufacturer Country | US |
| Manufacturer Postal | 55317 |
| Manufacturer Phone | 9524700866 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PMT HALO VEST |
| Generic Name | HALO |
| Product Code | ILZ |
| Date Received | 2009-12-10 |
| Returned To Mfg | 2009-11-18 |
| Model Number | 1233-5 |
| Lot Number | 090909 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PMT CORP |
| Manufacturer Address | 1500 PARK RD CHANHASSEN MN 55317 US 55317 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-12-10 |