MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-03-06 for S2800 SERIES MAXI-CHAIR S280000 manufactured by Global Surgical Corp..
[807481]
In 2008, global rec'd a call from one of our field rep that a 6 foot 5 inch pt weighing approx 325 pounds had fallen out of an examination chair when a cast iron structural back support failed allowing the chair back to fall beyond its full recline position. As a result of the event, the pt bumped his head on the floor. The pt was examined and mri results were found to be normal. Global immediately made a decision to stop production of the s2800 chair until further investigation had been completed. Parts were randomly selected from production and x-rayed by an independent metallurgical test lab. Results showed no obvious porosity or impurities in the casting that would have contributed to the failure. Global engineering was able to duplicate the field failure on two production chairs by adding 340 and 372 pounds to the chair backs while the chairs were in full recline position. Global engineering designed a reinforcing bracket that would prevent complete separation of the casting in the event of a failure and would prevent the chair from exceeding its full recline positon with then bracket added, the casting member was subjected to 498 pounds before it failed. The added bracket prevented the chair from falling past its full recline position and allowed it to continue to cycle through full range of functions. Support casting to be redesigned to provide greater strength. Reinforcing bracket to be installed on all chars that are currently in the field and those being manufactured until redesign casting becomes available.
Patient Sequence No: 1, Text Type: D, B5
[7991088]
Results: casting integrity compromised by a subsequent machining operation. Conclusions: incident was directly caused by failure of support casting. Explanation. Failed device was not returned. Unit not released by hosp.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1937051-2008-00001 |
| MDR Report Key | 1008987 |
| Report Source | 07 |
| Date Received | 2008-03-06 |
| Date of Event | 2008-02-20 |
| Date Mfgr Received | 2008-02-20 |
| Date Added to Maude | 2008-06-09 |
| 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 | 0 |
| Manufacturer Contact | JIM BLAUM |
| Manufacturer Street | 3610 TREE CT. INDUSTRIAL BLVD. |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6368615219 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S2800 SERIES MAXI-CHAIR |
| Generic Name | MEDICAL ENT EXAMINATION CHAIR |
| Product Code | HME |
| Date Received | 2008-03-06 |
| Model Number | S280000 |
| Catalog Number | S28 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1013820 |
| Manufacturer | GLOBAL SURGICAL CORP. |
| Manufacturer Address | 3610 TREE CT. INDUSTRIAL BLVD. ST. LOUIS MO 63122 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-06 |