MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-04-21 for ADVANCED CONTROL PAD SYSTEM 5943AP manufactured by Mizuho Orthopedic Systems, Inc..
[835310]
Customer complained that wo patients suffered skin abrasions after use on advanced control pad system.
Patient Sequence No: 1, Text Type: D, B5
[8025484]
Contacted risk management for the hospital, she was happy we called concerning her issues. She immediately stated that the table is currently in use and they are no longer having issues with the product. I asked if they were using patient kit covers over the pad and she was not sure. I asked if the anesthesiologist was monitoring the pressure points on the patient. She stated that they were no longer checking the pt because they believed the massaging action eliminated further need for pt monitoring. I informed her that the pads provide massaging actions. However, that should not eliminate the need to check for pressure problems with any patient. She also requested that the sales rep come into the hospital to complete an in-service training on the table system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2008-00010 |
| MDR Report Key | 1033064 |
| Report Source | 06 |
| Date Received | 2008-04-21 |
| Date of Report | 2008-04-15 |
| Date of Event | 2008-01-30 |
| Date Mfgr Received | 2008-02-07 |
| Device Manufacturer Date | 2007-08-31 |
| Date Added to Maude | 2009-08-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. KIRKE JAYNE |
| Manufacturer Street | 30031 AHERN AVE. |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104768125 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANCED CONTROL PAD SYSTEM |
| Generic Name | OPERATING ROOM TABLE |
| Product Code | FWY |
| Date Received | 2008-04-21 |
| Model Number | 5943AP |
| Catalog Number | 5943AP |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVENUE UNION CITY CA 94587123 US 94587 1234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 5803 | 1. Other | 2008-04-21 |