MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-06-18 for HEART RATE RESPIRATION MONITOR 9700A NA manufactured by Mallinckrodt.
[650589]
Parents claim monitor did not alarm at the time when there was a prolonged loose lead indication as detailed in the printout of the memory download. As a result the pt allegedly went for some period of time without monitoring as expected and then had an event that limited oxygen intake. The pt is reported to have suffered brain damage.
Patient Sequence No: 1, Text Type: D, B5
[7959340]
This monitor was named in a pt lawsuit that cas learned of on august 25, 2006. The actual monitor never returned to cas. It was only realized this week that the 30 day initial reporting deadline was in effect from the point in which cas was made aware of the incident, even if it was in the form of a suit being served. In an effort to manage the lawsuit the mdr reporting task was forgotten.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2244861-2007-00003 |
| MDR Report Key | 866694 |
| Report Source | 00 |
| Date Received | 2007-06-18 |
| Date of Report | 2007-06-14 |
| Date of Event | 2005-10-13 |
| Date Mfgr Received | 2006-08-25 |
| Device Manufacturer Date | 2000-06-01 |
| Date Added to Maude | 2008-02-13 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RON JEFFREY |
| Manufacturer Street | 44 EAST INDUSTRIAL RD. |
| Manufacturer City | BRANFORD CT 06405 |
| Manufacturer Country | US |
| Manufacturer Postal | 06405 |
| Manufacturer Phone | 2034886056 |
| Manufacturer G1 | MALLINCKRODT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEART RATE RESPIRATION MONITOR |
| Generic Name | BREATHING FREQUENCY MONITOR |
| Product Code | BZQ |
| Date Received | 2007-06-18 |
| Model Number | 9700A |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 959943 |
| Manufacturer | MALLINCKRODT |
| Manufacturer Address | 2800 NORTHWEST BLVD. PLYMOUTH MN 55441 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2007-06-18 |