MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-11-17 for INFINITY DOCKING STATION 7265338 7265338E5300 manufactured by Drager Medical Systems.
[555169]
It was communicated to us that while the customer was using our delta pt monitor that was connected to our ids (infinity docking station) the anesthesiologist slipped and hit the lower corner of the monitor with his arm. The monitor lifted off with the upper part of the docking station and resulted in the separation of the top cover section. (where the pt monitor is mounted) from the bottom section of the ids. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8053364]
The mfr draeger medical systems, inc. Received the ids (infinity docking station) correctly assembled. A representative from the mechanical engineering group evaluated the associated ids unit by performing a simulated functional test by installing a pt monitor on the associated ids unit and applying force in a way to possibly separate the top cover from the ids base component. The unit was also disassembled for further analysis. An inspection of the integrity of the pem fasteners was performed. This involved the removal of the ids top cover assembly to expose the fasteners. Each fastener was inspected for proper insertion into the molded plastic and appeared to be fine. Then a turning force was applied to each fastener to determine if the pem nut component was securely in place and would not move (spin or pull out). All pem nut fasteners stayed in place, none moved or pulled out of the molded plastic boss. After we had performed the above stated testing, we received info from our local field office that the pem fasteners had been glued into the molded plastic bosses after the reported event had occurred. Due to the applied glue on the pem fasteners, it was not possible to determine the root cause for the reported separation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220063-2006-00025 |
| MDR Report Key | 788459 |
| Report Source | 01 |
| Date Received | 2006-11-17 |
| Date of Report | 2006-11-15 |
| Date of Event | 2006-06-13 |
| Date Mfgr Received | 2006-06-13 |
| Date Added to Maude | 2006-12-04 |
| 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 | 0 |
| Manufacturer Contact | STEVE NAUGLE |
| Manufacturer Street | 6 TECH DRIVE |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9783798000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFINITY DOCKING STATION |
| Generic Name | POWER SUPPLY AND NETWORK COMMUNICATION DEVICE |
| Product Code | MPE |
| Date Received | 2006-11-17 |
| Returned To Mfg | 2006-07-17 |
| Model Number | 7265338 |
| Catalog Number | 7265338E5300 |
| Lot Number | 546576065 |
| ID Number | * |
| Operator | NO INFORMATION |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 776165 |
| Manufacturer | DRAGER MEDICAL SYSTEMS |
| Manufacturer Address | 6 TECH DR ANDOVER MA 01810 US |
| Baseline Brand Name | INFINITY DOCKING STATION |
| Baseline Generic Name | POWER SUPPLY AND NETWORK COMMUNICATION DEVICE |
| Baseline Model No | 7265338 |
| Baseline Catalog No | 7265338E5300 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-17 |