MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-08-09 for 970SE SMART MONITOR 970SE-10 manufactured by Respironics Inc.,.
[21252424]
Information was received alleging the device fails to alarm. The device was reportedly in patient use, however there was no reported patient harm or injury. The device was returned to the manufacturer for evaluation. During the repair evaluation, the customer's complaint of the device not alarming was confirmed. The device was evaluated by engineering for root cause of the alarm failure. The failure was caused by a damaged alarm board. The extent of mechanical damage to the alarm board and bottom enclosure is indicative of the device being dropped from a significant height or with extensive force.
Patient Sequence No: 1, Text Type: D, B5
[21343646]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2007-00062 |
| MDR Report Key | 891705 |
| Report Source | 05,06 |
| Date Received | 2007-08-09 |
| Date of Report | 2007-07-12 |
| Date of Event | 2007-07-12 |
| Date Mfgr Received | 2007-07-12 |
| Device Manufacturer Date | 2002-02-07 |
| Date Added to Maude | 2007-12-28 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHY DEPADUA |
| Manufacturer Street | 1001 MURRY RIDGE LN. |
| Manufacturer City | MURRYSVILLE PA 15866 |
| Manufacturer Country | US |
| Manufacturer Postal | 15866 |
| Manufacturer Phone | 7243877770 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 970SE SMART MONITOR |
| Generic Name | INFANT APNEA MONITOR |
| Product Code | BZQ |
| Date Received | 2007-08-09 |
| Returned To Mfg | 2007-07-19 |
| Model Number | 970SE-10 |
| Catalog Number | 970SE-10 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 938935 |
| Manufacturer | RESPIRONICS INC., |
| Manufacturer Address | 1001 MURRY RIDGE LN. MURRYSVILLE PA 156688550 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-09 |