MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-03 for AIRSEAL IFS 110V AS-IFS1 manufactured by W.o.m World Of Medicine Gmbh.
[189020177]
The report device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[189020178]
(b)(4) reported on behalf of their customer that the as-ifs1, airseal unit was used in case where the patient had a stroke. The air seal pressure setting was 12 mmhg. After the patient saturation has been decreasing, stroke occurred. The patient got paralysis on the left side. The doctor commented "the patient has atrial septal defect. Also the doctor confirmed there are possibilities that this would occurred when abdominal insufflation is done to the patient who has atrial septal defect from the anesthesiology department. " there is no indication that the airseal unit malfunctioned in any way. There is no actual complaint against the airseal, just that it was used in this procedure. Additional information and investigation has been requested but to date has not been received. As this was reported to the (b)(6) pdma by (b)(4), we are filing to the fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006217371-2019-00435 |
| MDR Report Key | 9545302 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-29 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-01-03 |
| 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 | 3 |
| Manufacturer Contact | MELANIE LANNON |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | W.O.M WORLD OF MEDICINE GMBH |
| Manufacturer Street | SALZUFER 8 4TH FLOOR |
| Manufacturer City | BERLIN, 10587 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 10587 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRSEAL IFS 110V |
| Generic Name | INSUFFLATION UNIT |
| Product Code | HIF |
| Date Received | 2020-01-03 |
| Catalog Number | AS-IFS1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.O.M WORLD OF MEDICINE GMBH |
| Manufacturer Address | SALZUFER 8 4TH FLOOR BERLIN, 10587 GM 10587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-03 |