MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07 report with the FDA on 1996-09-24 for INTERNAL RACK M1043-68001 manufactured by Hewlett-packard Co..
[7760181]
Analysis: the internal rack was returned to co for analysis. The unit was received in two separate halves, showing no anomalies or mechanical defects. All fourteen interlocking tabs appeared normal. The unit was reassembled using the normal manufacturing processes. The eval of the reassembled unit showed no anomalies. The rack was then disassembled and mechanically inspected. No problems were discovered. Pull tests on the fully assembled rack were unsuccessful in separating the two halves. The rack was turned over to the manufacturing engineering for their analysis. Experiments were performed to investigate the possibility that the top seven out of fourteen mechanical interlocks were not completely engaged. The results from these experiments indicated that with the rack partially assembled, the electrical integrity between the rack and rack interface connection is interrupted. No communication between the rack and the cmu was possible in this partially assembled state. Conclusion: the experiments performed on the returned internal rack were inconclusive. The rack exhibited no signs of mechanical fatigue or failure. Intentionally misassembling the rack resulted in loss of communication between the front end modules and the cmu. The cms is not functional in this mode. Equipment inop alarms would be generated in this mode of operation. The equipment has been in service for two years with no reports of rack specific failures. A review of co's service records doesn't show any similar occurrence of this problem.
Patient Sequence No: 1, Text Type: N, H10
[15378224]
While the pt was being monitored by the m1046a component monitoring system, the m1043-68001 internal rack which locks into the computer module came apart. The front end assembly with modules separated from the rear cover and fell upon the pt. The front end assembly turned in mid-air in such a manner that the circuit card struck the pt on the left side of the face near the jaw bone causing abrasions of the skin. The unit continued until it struck the collar bone in the left clavicle area, causing a small cut in the skin. The pt was given an x-ray examination. There were no further injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-1996-00006 |
| MDR Report Key | 39765 |
| Report Source | 04,05,06,07 |
| Date Received | 1996-09-24 |
| Date of Report | 1996-09-24 |
| Date of Event | 1996-09-10 |
| Date Facility Aware | 1996-09-10 |
| Report Date | 1996-09-24 |
| Date Reported to Mfgr | 1996-09-11 |
| Date Mfgr Received | 1996-09-11 |
| Device Manufacturer Date | 1994-09-01 |
| Date Added to Maude | 1996-09-30 |
| 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 | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERNAL RACK |
| Generic Name | INTERNAL RACK |
| Product Code | MOY |
| Date Received | 1996-09-24 |
| Model Number | M1043-68001 |
| Catalog Number | M1043-68001 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 24 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 40899 |
| Manufacturer | HEWLETT-PACKARD CO. |
| Manufacturer Address | 3000 MINUTEMAN RD ANDOVER MA 01810 US |
| Baseline Brand Name | INTERNAL RACK |
| Baseline Generic Name | INTERNAL RACK |
| Baseline Model No | M1043-68001 |
| Baseline Catalog No | M1043-68001 |
| Baseline ID | * |
| Baseline Device Family | INTERNAL RACK |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K882609 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-09-24 |