MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2009-04-23 for COMPRESSED GAS TANK HOLDER 0682000449 NA manufactured by Stryker Communications.
[19947880]
Lot number is unk. Making attempts to collect this info. There is no expiration date for this product. Actual device was not evaluated; similar device evaluated. Unk whether the initial reporter is a health professional and what his occupation is. Making attempts to follow-up with the initial reporter for this info. Ddevice manufactured date is unk. Making attempts to follow-up on this info. Inadequate design seems to be the root cause of this issue. Having only two fasteners available and the placement of these fasteners in parallel is likely the cause for the reported complaint. This is not a single-use device. Eval summary: e-cylinders are used to house co2 or nitrogen. The e-cylinder canister holder is used to suspend e-cylinders off the ground. The holder attaches to a fairfield rail which is attached to a boom. The revision a holder has an adapter which is attached to it by two fasteners; one on top of the other in parallel. The adapter is called a fairfield fray adapter (fta) and this is the device which connects the assembly to the boom. The account did not return the actual e-cylinder canister holder involved in the reported complaint. The quality engineering department conducted operational and visual inspections on an available e-cylinder canister holder of the mentioned revision received from the field. The engineers confirmed that the equipment is the same in terms of design and performance to the e-cylinder canister holder at the specified account. The purpose of the testing was to simulate the event conditions as reported by the initial reporter. Inadequate design seems to be the root cause of this issue. Having only two fasteners available and the placement of these fasteners in parallel is likely the cause for the reported complaint.
Patient Sequence No: 1, Text Type: N, H10
[19964566]
Per the sales representative, in operating room #4, the co2 tank holder fell. No pts were involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031963-2009-00006 |
| MDR Report Key | 1421300 |
| Report Source | 00,07 |
| Date Received | 2009-04-23 |
| Date of Report | 2009-03-25 |
| Date of Event | 2009-03-25 |
| Date Mfgr Received | 2009-03-25 |
| Date Added to Maude | 2009-08-20 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PETER KILPATRICK |
| Manufacturer Street | 1410 LAKESIDE PKWY. |
| Manufacturer City | FLOWER MOUND TX 75028 |
| Manufacturer Country | US |
| Manufacturer Postal | 75028 |
| Manufacturer Phone | 9724107100 |
| Manufacturer G1 | STRYKER COMMUNICATIONS |
| Manufacturer Street | 1410 LAKESIDE PKWY. |
| Manufacturer City | FLOWER MOUND TX 75028 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75028 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPRESSED GAS TANK HOLDER |
| Product Code | ECX |
| Date Received | 2009-04-23 |
| Model Number | 0682000449 |
| Catalog Number | NA |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER COMMUNICATIONS |
| Manufacturer Address | FLOWER MOUND TX 75028 US 75028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-23 |