MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-12-21 for 970 SE-10 HOSPITAL SMART MONITOR manufactured by Respironics, Inc..
[415643]
The unit's audible alarm was not sounding to specification. The unit was reportedly in patient use, however there was no reported patient harm. During repair evaluation, it was confirmed that the alarm was not functional because the wiring harness had come loose. Cause is unknown; however device had been in use for a number of years and may have been dropped. The wiring harness was reconnected to correct the problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-2005-00069 |
| MDR Report Key | 655239 |
| Report Source | 05,06 |
| Date Received | 2005-12-21 |
| Date of Report | 2005-12-01 |
| Date of Event | 2005-12-01 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2005-12-23 |
| 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 | LOU KINNEY |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE PA 15866 |
| Manufacturer Country | US |
| Manufacturer Postal | 15866 |
| Manufacturer Phone | 7243874292 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 970 SE-10 HOSPITAL SMART MONITOR |
| Generic Name | INFANT APNEA MONITOR |
| Product Code | BZQ |
| Date Received | 2005-12-21 |
| Model Number | 970 SE-10 |
| Catalog Number | 970 SE-10 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 644726 |
| Manufacturer | RESPIRONICS, INC. |
| Manufacturer Address | 1001 MURRY RIDGE LN. MURRYSVILLE PA 156688550 US |
| Baseline Brand Name | 970 SE-10 HOSPITAL SMART MONITOR |
| Baseline Generic Name | INFANT APNEA MONITOR |
| Baseline Model No | 970 SE-10 |
| Baseline Catalog No | 970 SE-10 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-21 |