MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-10 for ID-MTS READER SA MTS9945 manufactured by Micro Typing Systems, Inc..
[37184322]
This customer reported the lid of the reader sa was not staying open by itself. Customer did not claim alleged death or serious injury. On august 10, 2004, fe performed the following repairs: inspected the hinge and found the pin that connects the lid to the lid hinge mechanism shaft was missing and replaced the part. Fe confirmed lid was working properly after repairs, holding its position mid close and without dropping. Repairs returned equipment to expected operation. No injury occurred or was reported. In a letter issued march 4, 2004, customers were informed of the issue and asked to check the lid hinge mechanism and contact customer technical support if any issues were noted. Customers were also informed that field engineers would be performing additional actions at future service calls. These actions include inspection, lubrication and repair as necessary, of any issues with the lid hinge mechanism. Complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37184323]
Lid on reader sa could slam shut if hinge assembly is broken. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1058138-2004-00035 |
| MDR Report Key | 5305870 |
| Date Received | 2004-09-10 |
| Date of Report | 2004-09-10 |
| Date of Event | 2004-08-09 |
| Date Mfgr Received | 2004-08-09 |
| Device Manufacturer Date | 2002-11-01 |
| Date Added to Maude | 2015-12-17 |
| 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 | CATHERINE MCMULLEN, SITE DIRECTOR |
| Manufacturer Street | 1295 SW 29TH AVE |
| Manufacturer City | POMPANO BEACH FL 33069 |
| Manufacturer Country | US |
| Manufacturer Postal | 33069 |
| Manufacturer Phone | 9546239537 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ID-MTS READER SA |
| Generic Name | BLOOD GROUPING CENTRIFUGE AND READER |
| Product Code | KSO |
| Date Received | 2004-09-10 |
| Model Number | MTS9945 |
| Catalog Number | MTS READER SA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 SW 29TH AVE POMPANO BEACH FL 33069 US 33069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-09-10 |