MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-09-25 for PRIMA XTEND ARM 129244 manufactured by Hill-rom Architectural Products - Hill-rom Co. Inc.
[1244030]
The facilities engineer alleged the gcx bracket came loose from the prima xtend unit and fell on top of a crib. A pt was not in the crib. The nurse was in the process of getting the crib ready for a baby, and as she moved the monitor, the monitor arm fell on top of the crib. The facilities engineer was able to tighten the two screws on the bracket which secures the monitor arm to the prima xtend. He also checked several of the other units in the area and found loose screws.
Patient Sequence No: 1, Text Type: D, B5
[8397750]
The tech investigated and found monitor arm bracket screws came loose. He did not see loctite on the screws and reinstalled the screws using loctite. All units at this account were checked and loctite was added to each of the screws. The tech indicated that the monitors are moved around a lot at this facility and recommended that the facility tighten the screws as part of an annual preventative maintenance program.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1836145-2009-00002 |
| MDR Report Key | 1507336 |
| Report Source | 00 |
| Date Received | 2009-09-25 |
| Date of Report | 2009-08-27 |
| Date of Event | 2009-08-26 |
| Date Mfgr Received | 2009-08-27 |
| Date Added to Maude | 2010-07-14 |
| 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 | MARK VORNHEDER |
| Manufacturer Street | 1069 STATE RT 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129347163 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIMA XTEND ARM |
| Generic Name | SUSPENSION ARM |
| Product Code | IYB |
| Date Received | 2009-09-25 |
| Model Number | 129244 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM ARCHITECTURAL PRODUCTS - HILL-ROM CO. INC |
| Manufacturer Address | WEST PEARL AND WALNUT STS BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-25 |