MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-05-04 for CARDIOPERFECT WORKSTATION (CPWS) SPIROPERFECT KIT 703554 manufactured by Welch Allyn.
[20954833]
Welch allyn was made aware, through a distributor (b)(6), that an unknown foreign object was in the disposable spirometer flow transducer. Twice the pt had the object enter her mouth at the start of the procedure, but no report of the object going into the pt's windpipe/trachea. The pt spat the object out and continued with the procedure. There was no report of any injury as a result of this event and no report that pt inhaled the object.
Patient Sequence No: 1, Text Type: D, B5
[21211253]
Multiple attempts have been made to contact the facility to obtain additional info about this allegation without success. The flow transducer used on the aforementioned pt was not made available to welch allyn for evaluation. The distributor indicated the pt was wrongly instructed to bite down on the flow transducer by the clinician. Welch allyn does not know what the foreign material was or how it made it's way into the flow transducer. Welch allyn purchases and distributes the spiroperfect kit (catalog number 703554) and single-flow transducers (catalog numbers 703418 (25 pk) and 703419 (100 pk)) from (b)(4). Welch allyn informed (b)(4) in writing of this event on 03/14/2011; (b)(4) originally submitted a medical device report on or about 04/07/2011. Method code (other) - other device not returned, unable to confirm allegation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2012-00002 |
| MDR Report Key | 2573861 |
| Report Source | 01,05 |
| Date Received | 2012-05-04 |
| Date of Report | 2011-02-10 |
| Date of Event | 2011-02-10 |
| Date Mfgr Received | 2011-02-10 |
| Date Added to Maude | 2012-08-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PEARLEY BHAMBRI, SR. MANAGER |
| Manufacturer Street | 4341 STATE ST. RD. |
| Manufacturer City | SKANEATELES FALLS NY 13152 |
| Manufacturer Country | US |
| Manufacturer Postal | 13152 |
| Manufacturer Phone | 3156852568 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOPERFECT WORKSTATION (CPWS) |
| Product Code | BZG |
| Date Received | 2012-05-04 |
| Model Number | SPIROPERFECT KIT |
| Catalog Number | 703554 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | 4341 STATE ST. RD. SKANEATELES FALLS NY 13152 US 13152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-04 |