MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2016-03-21 for RESOLVE HALO VEST SHORT LAMSWOOL 545700L manufactured by Ossur Americas, Inc..
[40772809]
The vest currently provides instructions for emergency access to the chest as shown in the photo attached. Further details will be gathered from the hospital and we will provide a follow up report.
Patient Sequence No: 1, Text Type: N, H10
[40772810]
Patient was wearing halo vest and required emergency cpr. The staff did not know the correct procedure to remove the vest to administer cpr. The patient died.
Patient Sequence No: 1, Text Type: D, B5
[48831341]
The vest currently provides instructions for emergency access to the chest as shown in the photo attached. We have initiated a preventative action to maximize the visibility of the emergency label and/or change the labels to symbols rather than text. -
Patient Sequence No: 1, Text Type: N, H10
[48831342]
Patient was wearing halo vest and required emergency cpr. The staff did not know the correct procedure to remove the vest to administer cpr. The patient died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836248-2016-00002 |
| MDR Report Key | 5513714 |
| Report Source | FOREIGN |
| Date Received | 2016-03-21 |
| Date of Report | 2016-03-21 |
| Date Mfgr Received | 2016-03-16 |
| Date Added to Maude | 2016-03-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE DRIVE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823741 |
| Manufacturer G1 | OSSUR AMERICAS, INC. |
| Manufacturer Street | 910 BURSTEIN DRIVE |
| Manufacturer City | ALBION MI 49224 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49224 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESOLVE HALO VEST SHORT LAMSWOOL |
| Generic Name | COMPONENT, TRACTION, NON-INVASIVE |
| Product Code | KQZ |
| Date Received | 2016-03-21 |
| Model Number | 545700L |
| Catalog Number | 545700L |
| Operator | PARAMEDIC |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR AMERICAS, INC. |
| Manufacturer Address | 910 BURSTEIN DRIVE ALBION MI 49224 US 49224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-03-21 |