MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06,07 report with the FDA on 2002-01-30 for LAERDAL INFLATE-A-SHIELD 490000 manufactured by Laerdal Medical Corp..
[241069]
This customer received a sample lis (laerdal inflate-a-shield) that was defective and would not inflate. The customer found the defect upon opening the package. The sample was provided to the customer to be evaluated for use in training classes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2425852-2001-00003 |
| MDR Report Key | 374638 |
| Report Source | 00,06,07 |
| Date Received | 2002-01-30 |
| Date of Report | 2001-11-13 |
| Report Date | 2001-11-13 |
| Date Mfgr Received | 2001-11-14 |
| Device Manufacturer Date | 2001-05-01 |
| Date Added to Maude | 2002-02-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LINDA LORAIN |
| Manufacturer Street | 167 MYERS CORNERS ROAD |
| Manufacturer City | WAPPINGERS FALLS NY 129508840 |
| Manufacturer Country | US |
| Manufacturer Postal | 129508840 |
| Manufacturer Phone | 8452977770 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAERDAL INFLATE-A-SHIELD |
| Generic Name | CPR SHIELD - BARRIER DEVICE |
| Product Code | CBP |
| Date Received | 2002-01-30 |
| Returned To Mfg | 2001-11-14 |
| Model Number | NA |
| Catalog Number | 490000 |
| Lot Number | 080301 |
| ID Number | 510K# K001742 |
| Operator | OTHER |
| Device Availability | R |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 363761 |
| Manufacturer | LAERDAL MEDICAL CORP. |
| Manufacturer Address | 167 MYERS CORNERS RD. WAPPINGERS FALLS NY 125908840 US |
| Baseline Brand Name | LAERDAL INFLATE-A-SHEILD |
| Baseline Generic Name | CPR SHIELD-BARRIER DEVICE |
| Baseline Model No | NA |
| Baseline Catalog No | 490000 |
| Baseline ID | 510K#K001742 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-01-30 |