MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-03-23 for AUTO LOGIC 630004BE manufactured by Getinge (suzhou) Co. Ltd..
[2572171]
Patient admitted since (b)(6) 2011 on service sp loco, high pressure ulcer risk. Started with alx in rental fleet, afterwards replaced with al110. Replaced 1st time with new pump due to bottoming out, second time same problem. Patient already had pressure ulcer wound, but healed after weekend at home. On (b)(6), new wound. Mr. (b)(6) also noticed there was a crack in the seat cushion in the wheelchair. This could have caused the wound. Patient treated for wound care according to hospital protocol.
Patient Sequence No: 1, Text Type: D, B5
[9704159]
This report is being filed exemption (b)(4) by arjohuntleigh (registration #1419652) on behalf of the manufacturer getinge (b)(4) (registration #3005619970). Mfr complaint #(b)(4). It has been reported to the manufacturer that an incident has occurred using our: auto logic (al110) system, comprising of an alternating pressure redistribution mattress and a pump. On the (b)(6), the patient was recorded as having a category 3 pressure ulcer (unknown as to the location of the injury). In addition to the details recorded in this report, the following was also identified: device was examined and the general condition was recorded as "mattress and pump are in good condition" with good results observed from a functional test. There was no recorded alterations to the system prior to use and it was not possible to recreate the event. Th actual device has not been involved in any similar incident in the last year. The ifu (user manual) was available to the user, however, the preventative maintenance schedule for this device is not available at this moment. The device is not under any arjohuntleigh service contract, but may be under a rental agreement with our rental department. The information contained in this initial report is based upon the information provided to the manufacturer by representatives of the manufacturer's sales and service unit subsidiary division. Additional information will be provided following the conclusion of the manufacturer's investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005619970-2012-00002 |
| MDR Report Key | 2508560 |
| Report Source | 01,06 |
| Date Received | 2012-03-23 |
| Date of Report | 2012-02-24 |
| Date of Event | 2012-02-24 |
| Date Facility Aware | 2012-03-09 |
| Report Date | 2012-03-23 |
| Date Reported to FDA | 2012-03-23 |
| Date Reported to Mfgr | 2012-03-23 |
| Date Mfgr Received | 2012-02-24 |
| Date Added to Maude | 2012-03-30 |
| 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 | STEVE HELLSTROM |
| Manufacturer Street | 2349 WEST LAKE ST. |
| Manufacturer City | ADDISON IL 60101 |
| Manufacturer Country | US |
| Manufacturer Postal | 60101 |
| Manufacturer Phone | 8003231245 |
| Manufacturer G1 | GETINGE (SUZHOU) CO. LTD. |
| Manufacturer Street | NO. 158 FANGZHOU ROAD |
| Manufacturer City | SIP, SUZHOU, JIANGSU 215024 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215024 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTO LOGIC |
| Generic Name | PAC |
| Product Code | JJJ |
| Date Received | 2012-03-23 |
| Model Number | 630004BE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE (SUZHOU) CO. LTD. |
| Manufacturer Address | SUZHOU CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-03-23 |