MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,08 report with the FDA on 2007-06-29 for 970SE SMART MONITOR manufactured by Respironics Inc..
[15003679]
Info was received that alleges a faulty device contributed to the death of a pt. The alleged event reportedly occurred during 2006, the exact date is not known at this time. The nature of the alleged device malfunction is unk at this time. The device reportedly sat on a shelf in a police dept for an extended time without being plugged into an electrical outlet. After charging the device, the customer performed a memory download and the output read "no waveform available". The device was returned to the mfr for eval and memory download. When the down load was attempted, it appeared that the device memory may have cleared or lost due to a depleted battery. An evaluation was performed and the device was found to operate and alarm to specification. No add'l info is available at this time. If add'l info becomes available, a follow up report will be filed.
Patient Sequence No: 1, Text Type: D, B5
[15457437]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2007-00058 |
| MDR Report Key | 873063 |
| Report Source | 00,05,08 |
| Date Received | 2007-06-29 |
| Date of Report | 2007-06-07 |
| Date of Event | 2006-04-01 |
| Date Mfgr Received | 2007-06-07 |
| Device Manufacturer Date | 1998-08-01 |
| Date Added to Maude | 2007-07-02 |
| 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 | RESPIRATORY THERAPIST |
| 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 |
| Remedial Action | OT |
| 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 | 2007-06-29 |
| Returned To Mfg | 2007-06-13 |
| Model Number | 970SE |
| Catalog Number | 970SE |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 853622 |
| Manufacturer | RESPIRONICS INC. |
| Manufacturer Address | 1001 MURRY RIDGE LN. MURRYSVILLE PA 156688550 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-06-29 |