MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-12-11 for SEDATION SYSTEMS CA0120MX manufactured by Globalmed Inc..
[3099070]
See maude event report (b)(4) included with fda letter dated (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
[10484495]
The product (i. E. Device) was leak tested by mfr prior to being released for shipment using the industry standard (iso 63676:2000 annex d). Request was made to return to mfr one unopened case of product (b)(4) (10 pieces) as well as the alleged defective sample tested and referred to in maude event report ((b)(4)). Only the one case of unopened product was returned to mfr (lot # 90815). All 10 pieces were leak tested during the above iso standard and found to meet the standard. Additionally, all 10 pieces were found free of any defects or abnormalities. (b)(6) letter dated (b)(6) 2012. Inasmuch as the actual sample "screened" by the hospital as described in maude event report (b)(4), and forming the basis of the "headache" complaint, was not returned to mfr for eval (despite repeated requests), the root cause of the "headache" complained of in (b)(4) cannot be determined or attributed to any malfunctioning or defective product. Upon info and belief, the hospital has continued to order and use the product ((b)(4)) subsequent to filing of the maude event report. It is noted that the maude event report (b)(4) does not state that the sample "screened" was the direct cause of the complained of "headache," merely that there was a 'headache" by an unidentified individual and that a product sample was "screened". It also is noted that lot's cited in the maude report are different than those alleged by the hospital's rep, (b)(6), as requiring eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007143859-2012-00001 |
| MDR Report Key | 2879560 |
| Report Source | 99 |
| Date Received | 2012-12-11 |
| Date of Report | 2012-12-06 |
| Date of Event | 2012-10-05 |
| Date Facility Aware | 2012-11-16 |
| Report Date | 2012-12-06 |
| Date Reported to FDA | 2012-10-26 |
| Date Reported to Mfgr | 2012-11-19 |
| Device Manufacturer Date | 2012-05-12 |
| Date Added to Maude | 2013-02-14 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEDATION SYSTEMS |
| Generic Name | RESPIRATORY MASK AND BREATHING CIRCUIT |
| Product Code | BSJ |
| Date Received | 2012-12-11 |
| Returned To Mfg | 2012-10-11 |
| Catalog Number | CA0120MX |
| Lot Number | 90815 |
| ID Number | 36600921 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLOBALMED INC. |
| Manufacturer Address | TRENTON, ON CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-11 |