MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-06 for BD MAX INSTRUMENT 441916 manufactured by Bd Diagnostic Systems.
[4376771]
The customer called to report that this bd max instrument is having door issues. The door is loose and when opened will slide closed on its own. Door has come close to dropping on customer while they are placing racks inside and cleaning the instruments. The customer contacted the bd technical service and support department for an engineer to be dispatched for repair. A field service engineer found that the "l" shaped lever between the gas shock and the hinge was worn out and required replacement. The fse repaired and tested the door. The door is now functioning as intended. The bd max system is intended for in vitro diagnostic (ivs) use in performing nucleic acid testing in clinical laboratories. The bd max system is capable of automated extraction and purification of nucleic acids from multiple specimen types, as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based pcr.
Patient Sequence No: 1, Text Type: D, B5
[11827566]
The device did not lead to death or serious deterioration in the health of a patient or user; however, information does suggest that if the device malfunction were to recur, it could contribute to an injury. The bd quality department investigated the complaint of the bd max instrument door being difficult to open and slamming down. The complaint was confirmed by the field service engineer on-site. The investigation by the fse found that the "l" shaped lever was damaged, which indicates incorrect assembly/disassembly of the gas spring occurred at some point previous to this failure. Investigation is unable to determine when this occurred. The door hinge assembly was replaced and remounted to the gas spring arm. The door is operating as expected. This is an isolated incident and there are no trends for this failure mode. No further action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2014-00001 |
| MDR Report Key | 3777277 |
| Report Source | 05 |
| Date Received | 2014-01-06 |
| Date of Report | 2013-10-31 |
| Date of Event | 2013-10-31 |
| Date Mfgr Received | 2013-10-31 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2014-05-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BD DIAGNOSTIC SYSTEMS |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD MAX INSTRUMENT |
| Product Code | OOI |
| Date Received | 2014-01-06 |
| Catalog Number | 441916 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD DIAGNOSTIC SYSTEMS |
| Manufacturer Address | SPARKS MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-06 |