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 2019-03-25 for RC manufactured by Getinge Disinfection Ab.
[139686554]
(b)(4). The issue is being investigated by manufacturing site.
Patient Sequence No: 1, Text Type: N, H10
[139686555]
On (b)(6) 2019 we became aware of an issue with loading equipment outside machine- rc (return conveyor). As it was stated, the end pin of conveyor was stuck in "down" position resulting in situation when cart detached from it and fell down. The rc is a supplemental product to the washer disinfectors model number cm320 and 88-series registered as the medical device. There was no injury reported related to this issue. However having in mind similar cases and considering the worse case scenario we decided to report this issue based on the potential, as it might lead to an adverse event if it was to reoccur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616031-2019-00010 |
| MDR Report Key | 8447159 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-25 |
| Date of Report | 2019-05-28 |
| Date Facility Aware | 2018-03-18 |
| Date Mfgr Received | 2019-03-18 |
| Device Manufacturer Date | 2015-01-08 |
| Date Added to Maude | 2019-03-25 |
| 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 | MR DENNIS GENITO |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097515 |
| Manufacturer G1 | GETINGE DISINFECTION AB |
| Manufacturer Street | LJUNGADALSGATAN 11 KRONOBERGS LAN [SE-07] |
| Manufacturer City | VAXJO, 35115 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 35115 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RC |
| Generic Name | RC |
| Product Code | PEC |
| Date Received | 2019-03-25 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE DISINFECTION AB |
| Manufacturer Address | LJUNGADALSGATAN 11 KRONOBERGS LAN [SE-07] VAXJO, 35115 SW 35115 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-25 |